MetastasisPhase 1/2HAMMERNCT04009681
A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)
A Phase 1/2 study testing THOR-707, Checkpoint inhibitor and anti-EGFR antibody in people with Metastasis, run by Synthorx, Inc, a Sanofi company at 24 sites in 6 countries.
Trial summary
Primary Objectives: Evaluate the safety and tolerability of THOR-707 as a single agent and as a combination therapy (identify Dose Limiting Toxcitiy (DLTs) in Cohorts A, B, C, D, and G, and adverse events (AEs)/serious adverse event (SAE) profile in Cohorts A, B, C, D, E, F, and G) Define the Maximium Tolerated Dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis
- What is being tested?
- THOR-707, Checkpoint inhibitor and anti-EGFR antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 20 Jun 2019to 2 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Measurable disease per RECIST v1.1. For Cohort G participants must have at least 1 measurable lesion, and for Part 3 (Cohorts E, F and H) participants must have at least 2 measurable lesions to safely perform mandatory pre \& on-treatment biopsy.
- Life expectancy greater than or equal to 12 weeks.
- For Part 2 exclusively: While it is highly preferred to enroll subjects who are naïve to PD-1 inhibitors into a Part 2 dose escalation cohort, this is not an enrollment requirement. However, subjects who enroll into a Part 2 safety expansion cohort must be naïve to PD-1 inhibitors. If such subject is unable to meet this requirement but otherwise remains a good candidate for study enrollment, the Investigator should discuss with the Sponsor whether the subject may be enrolled.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate cardiovascular, hematological, liver, and renal function.
- Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumors with at least one tumor lesion with location accessible to safely biopsy per clinical judgment of the Investigator.
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- Caution: Cohort D only patients with KRAS mutant colon cancer have not typically benefitted from the addition of cetuximab in earlier lines of therapy.
- Caution: Cohorts E \& F enrollment will include only patients with tumors for which anti-PD(L)1 as single agent or in combination treatments are approved.
- Caution: For Cohort H, the participant must have received at least one prior line of therapy for metastatic melanoma and/or does not have any standard of care (SoC) treatment option or participant declines or is intolerant to be treated with SoC treatment.
- Subjects with advanced or metastatic solid tumors who have refused SoC; or for whom no reasonable SoC exists that would confer clinical benefit; or for whom standard therapy is intolerable, not effective, or not accessible.
- Prior anti-cancer therapy is allowed as long as any treatment related toxicity is resolved to an appropriate level.
- Females of childbearing potential and men who are not surgically sterile must agree to use medically-accepted method of birth control during the study and for at least7 days (for Cohorts A, B, G and H), at least 2 months (for Cohort D), or at least 4 months (for Cohorts C, E and F) for females, and for at least 3 days for males [corresponding to the time needed to eliminate study intervention] after the last dose of study intervention.
- [Females] Negative serum pregnancy test within 7 days prior to initiating study treatment in premenopausal women and women less than 12 months after menopause.
- [Males] Agreement to refrain from donating or banking sperm during the treatment period and for at least 3 days after last dose of study treatment.
- In Spain, Chile, and Argentina: Only cohorts G and H will be open to enrollment.
Who cannot join
- Radiotherapy ≤ 14 days prior to first dose of study drug (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment).
- Treated with systemic anti-cancer therapy or an investigational agent within 2 weeks prior to start of study drug treatment (within 4 weeks for immunotherapy and tyrosine kinase inhibitor therapy).
- Subjects who experienced Grade 3 or higher immune-related toxicity from prior immuno-oncology therapy.
- Major surgery ≤ 30 days prior to first dose of study drug, or has not recovered to at least Grade 1 from adverse effects from such procedure, or anticipation of the need for major surgery during study treatment.
- Active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
- Primary central nervous system (CNS) disease or leptomeningeal disease; known CNS metastases unless treated, are asymptomatic, are without evidence of radiological progression for at least 8 weeks, and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days prior to Screening.
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- Abnormal pulmonary function within the previous 6 months, including pneumonitis, active pneumonitis, interstitial lung disease requiring the use of steroids, idiopathic pulmonary fibrosis, confirmed pleural effusion, severe dyspnea at rest or requiring supplementary oxygen therapy.
- Parenteral antibiotics within 14 days of the first dose of study drug.
- History of allogenic or solid organ transplant.
- Uncontrolled diabetes mellitus or other uncontrolled immune-related endocrinopathies in the opinion of the Investigator.
- Known human immunodeficiency virus (HIV) infection or active infection with hepatitis C.
- For known uncontrolled hepatitis B virus (HBV) infection:
- Anti-HBV therapy started before initiation of IMP and HBV viral load <2000 IU/mL (104 copies/mL) are eligible. The anti-HBV therapy should continue throughout the treatment period. ii. Positive anti-HBc, positive anti HBs, negative HBsAg, and HBV virus load without HBV therapy are eligible.
- Received a live-virus vaccination ≤14 days prior to first dose of study drug. Seasonal flu and other inactivated vaccines that do not contain live virus are permitted.
- Clinically significant bleeding within 2 weeks prior to initial THOR-707 dose (e.g., gastrointestinal bleeding, intracranial hemorrhage).
- Prior diagnosis of deep vein thrombosis or pulmonary embolism within 3 months.
- Severe or unstable cardiac condition within 6 months prior to starting study treatment, such as congestive heart failure (New York Heart Association Class III or IV), cardiac bypass surgery or coronary artery stent placement, angioplasty, cardiac ejection fraction below the lower limit of normal, unstable angina, medically uncontrolled hypertension (e.g. ≥160 mm Hg systolic or ≥100 mm Hg diastolic), uncontrolled cardiac arrhythmia requiring medication (≥ grade 2, according to NCI CTCAE v5.0), or myocardial infarction.
- History of non-pharmacologically induced prolonged corrected QT interval determined using Fridericia's formula (QTcF) > 450 milliseconds (msec) in males or > 470 msec in females.
- Known hypersensitivity or contraindications to any components of THOR-707, PEG, pegylated drugs, and E. coli derived-protein, checkpoint inhibitor, or anti-EGFR antibody for applicable cohorts.
- Active second malignancy, or history of previous malignancy that would impact the assessment of any study endpoints. Subjects with non-melanomatous skin cancer or cervical cancer that has been curatively surgically resected are eligible.
- Any serious medical condition (including pre-existing autoimmune disease or inflammatory disorder), laboratory abnormality, psychiatric condition, or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy or would make the subject inappropriate for the study.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through for at least 7 days (for Cohorts A, B, G, and H), at least 2 months (for Cohort D), or at least 4 months (for Cohorts C, E, and F) for females and for at least 3 days for males [corresponding to the time needed to eliminate study intervention] after the last dose of study intervention.
- Concurrent therapy with any other investigational agent, vaccine, or device. Concomitant participation in observational studies is acceptable after Sponsor approval.
- For Cohort D only: patients with symptomatic keratitis and/or symptomatic dry eye should be excluded from enrollment. Patients who wear contact lenses should be advised to avoid contact lenses use as it could result in keratitis.
- Subjects with baseline oxygen saturation <92% are not eligible for enrollment.
- For participants in Cohort H: Participants with uveal or ocular or desmoplastic metastatic melanoma.
- The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Spain8 sites
Investigational Site Number-5001
Barcelona
Investigational Site Number-5006
Barcelona
Investigational Site Number-5007
Barcelona
Investigational Site Number-5002
Madrid
Investigational Site Number-5003
Madrid
Investigational Site Number-5004
Madrid
Investigational Site Number-5005
Madrid
Investigational Site Number-5105
Madrid
United States7 sites
Investigational Site Number-1007
Dallas, Texas, 75032
Investigational Site Number-1005
Denver, Colorado, 80218
Investigational Site Number-1002
Houston, Texas, 77030
Investigational Site Number-1003
Nashville, Tennessee, 37203
Investigational Site Number-1001
San Antonio, Texas, 78229
Investigational Site Number-1004
Sarasota, Florida, 34232
Investigational Site Number-1008
Scottsdale, Arizona, 85250
Australia4 sites
Investigational Site Number-2004
New South Whales
Investigational Site Number-2001
Perth
Investigational Site Number-2002
Victoria
Investigational Site Number-2003
Victoria
Chile2 sites
Investigational Site Number- 6001
Santiago
Investigational Site Number-6002
Santiago
Singapore2 sites
Investigational Site Number-4002
Singapore
Investigational Site-4001
Singapore
About this study
Official title: An Open-Label, Multicenter Phase 1/2 Dose Escalation and Expansion Study of THOR-707 as a Single Agent and as a Combination Therapy in Adult Subjects With Advanced or Metastatic Solid Tumors
Primary Objectives:
- Evaluate the safety and tolerability of THOR-707 as a single agent and as a combination therapy (identify Dose Limiting Toxcitiy (DLTs) in Cohorts A, B, C, D, and G, and adverse events (AEs)/serious adverse event (SAE) profile in Cohorts A, B, C, D, E, F, and G)
- Define the Maximium Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of THOR-707 as a single agent and as a combination therapy (Cohorts A, B, C, D, and G)
- Evaluate preliminary anti-tumor activity of THOR-707 as a single agent by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohort H only)
Read more
Secondary Objectives:
- Evaluate preliminary anti-tumor activity of THOR-707 as a single agent and as a combination therapy by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohorts A, B, C, D, E, F, and G)
- Determine time to response (TTR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and clinical benefit rate (CBR) of THOR-707 as a single agent and as a combination therapy
- Evaluate the safety and tolerability of THOR-707 monotherapy QW/Q2W (AE/serious adverse event [SAE] profile) (Cohort H only).
Read the detailed description
The study duration per participant is approximately 24 months (inclusive of follow-up). Cohorts A, B, C, and D have been completed.
- Conditions
- Metastasis
- Being tested
- THOR-707, Checkpoint inhibitor, anti-EGFR antibody
- Keywords
- Synthorx, THOR-707, THOR 707, Interleukin 2, Interleukin-2, IL2, oncology, immuno-oncology, immunotherapy, IL-2, SAR444245, Sanofi
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THOR-707Drug
Also called SAR444245, Pegenzileukin
Pharmaceutical form: solution for intravenous (IV) administration; Route of administration: IV administration
Checkpoint inhibitorDrug
Also called pembrolizumab
Pharmaceutical form: solution for IV administration; Route of administration: IV administration
anti-EGFR antibodyDrug
Also called cetuximab
Pharmaceutical form: solution for IV administration; Route of administration: IV administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort A-THOR-707 Q2W Monotherapy (Dose Escalation) | Experimental | Subjects with advanced or metastatic solid tumors will receive THOR-707 in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W) until unacceptable toxicity, disease progression, or withdrawal of consent. Receives: Drug: THOR-707 |
| Cohort B-THOR-707 Q3W Monotherapy (Dose Escalation) | Experimental | Subjects with advanced or metastatic solid tumors will receive THOR-707 in sequential ascending doses as a monotherapy via IV administration every 3 weeks (Q3W) until unacceptable toxicity, disease progression, or withdrawal of consent. Receives: Drug: THOR-707 |
| Cohort C-THOR-707 Q3W with checkpoint inhibitor (Dose Escalation) | Experimental | Subjects with advanced or metastatic solid tumors will receive THOR-707 Q3W in sequential ascending doses in combination with a checkpoint inhibitor Q3W or every 6 weeks (Q6W) via IV administration until unacceptable toxicity, disease progression, or withdrawal of consent. Receives: Drug: THOR-707; Drug: Checkpoint inhibitor |
| Cohort D-THOR-707 Q3W with anti-EGFR antibody (Dose Escalation) | Experimental | Subjects with advanced or metastatic solid tumors will receive THOR-707 Q3W in sequential ascending doses in combination with an anti-EGFR antibody weekly dosing (QW) via IV administration until unacceptable toxicity, disease progression, or withdrawal of consent. Receives: Drug: THOR-707; Drug: anti-EGFR antibody |
| Cohort E-THOR-707 Q2W with checkpoint inhibitor (Dose Expansion) | Experimental | Subjects with advanced or metastatic solid tumors will receiveTHOR-707 Q2W at recommended Phase 2 dose (RP2D) with a checkpoint inhibitor via IV administration Q6W; it will consist of one 8-week cycle of THOR-707 monotherapy on Cycle 1 Day 1 followed by THOR-707 Q2W + checkpoint inhibitor Q6W starting at Cycle 1 Day 15. Subsequently treatment will consist of repeated 6-week cycles with combination therapy. Receives: Drug: THOR-707; Drug: Checkpoint inhibitor |
| Cohort F-THOR-707 Q3W with checkpoint inhibitor (Dose Expansion) | Experimental | Subjects with advanced or metastatic solid tumors will receive THOR-707 Q3W at recommended Phase 2 dose (RP2D) with a checkpoint inhibitor via IV administration Q6W will consist of one 9-week cycle of THOR monotherapy on Cycle 1 Day 1 followed by THOR-707 Q3W + checkpoint inhibitor at Cycle 1 Day 22. Subsequently treatment will consist of repeated 6-weeks cycles with combination therapy. Receives: Drug: THOR-707; Drug: Checkpoint inhibitor |
| Cohort G Monotherapy QW/Q2W (Dose Escalation) | Experimental | Subjects with advanced or metastatic solid tumors will receive THOR707 monotherapy QW for 6 weeks (induction period), and then every Q2W (maintenance period), which is referred as QW/Q2W thereafter, until unacceptable toxicity, disease progression, or withdrawal of consent. Receives: Drug: THOR-707 |
| Cohort H Monotherapy QW/Q2W (Dose Expansion) | Experimental | Subjects with late-line metastatic melanoma will receive THOR707 monotherapy at RP2D for Cohort G. Cycle 1 will consist of THOR-707 QW for 6 weeks; Cycle 2 and beyond will consist of THOR-707 Q2W. Receives: Drug: THOR-707 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Dose-Limiting Toxicities (DLTs)- Cohorts A, B, C, and D
Based on toxicities observed
Measured: Study Day 1 up to Day 29
Maximum Tolerated Dose (MTD)- Cohorts A, B, C, and D
Based on toxicities observed
Measured: Study Day 1 up to Day 29
Recommended Phase 2 Dose (RP2D)- Cohorts A, B, C, and D
Based on toxicities observed
Measured: Study Day 1 up to Day 29
Number of participants with treatment emergent adverse events, serious adverse events, and laboratory abnormalities - Cohorts A, B, C, D, E, F, and G
Safety will be assessed by monitoring adverse events, clinical laboratory evaluations, vital signs, and ECG parameters.
Measured: Study Day 1 up to approximately 24 months
Rate of Dose-Limiting Toxicities (DLTs) -Cohort G
Based on toxicities observed
Measured: Study Day 1 up to Day 42 (6 week-cycle)
Recommended Phase 2 Dose (RP2D) of THOR-707- Cohort G
Based on toxicities observed
Measured: Study Day 1 up to Day 42 (6 week-cycle)
Maximum Tolerated Dose (MTD)- Cohort G
Based on toxicities observed
Measured: Study Day 1 up to Day 42 (6 week-cycle)
Objective Response Rate (ORR) according to RECIST version 1.1 -Cohort H
ORR, defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.
Measured: Study Day 1 up to approximately 24 months
Secondary outcomes (8)
Objective Response Rate (ORR) according to RECIST version 1.1 Cohort A, B, C, D, E, F, and G)
Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.
Measured: Study Day 1 up to approximately 24 months
Duration of Response (DOR) according to RECIST version 1.1
Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Measured: Study Day 1 up to approximately 24 months
Progression-Free Survival (PFS) according to RECIST version 1.1
Defined as the time from first dose of THOR-707 to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Measured: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Overall Survival according to RECIST version 1.1
Defined as the time from first dose of THOR-707 to the date of death due to any cause.
Measured: Study Day 1 up to time of death, assessed up to approximately 24 months
Time to Response (TTR) according to RECIST version 1.1
Defined as the time from first dose of THOR-707 to first documentation of objective response (either CR or PR).
Measured: Study Day 1 up to approximately 24 months
Disease Control Rate (DCR) according to RECIST version 1.1
Defined as the proportion of subjects who have achieved confirmed CR, PR, or stable disease (SD) determined by Investigator per RECIST 1.1.
Measured: Study Day 1 up to approximately 24 months
Clinical Benefit Rate (CBR)
Defined as the proportion of participants with clinical benefit i.e., confirmed CR or PR as BOR (is defined as the best overall response observed from the date of first IMP until disease progression, death, cut-off date or initiation of subsequent anti-cancer therapy, whichever occurs first), or SD lasting at least 6 months.
Measured: Study Day 1 up to approximately 24 months
Number of participants with treatment emergent adverse events, serious adverse events, laboratory abnormalities -Cohort H
Safety will be assessed by monitoring adverse events, clinical laboratory evaluations, vital signs, and ECG parameters.
Measured: Study Day 1 up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start20 Jun 2019
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Why it stopped: The study was terminated as per Sponsor decision. The decision was not related to any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthorx, Inc, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009681
- Sponsor's protocol ID
- THOR-707-101 (TCD16843)
- Other IDs
- U1111-1298-7281, 2023-508422-95-00, 2023
- Acronym
- HAMMER
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2019
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Phase 1/2 Dose Escalation and Expansion Study of THOR-707 as a Single Agent and as a Combination Therapy in Adult Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04009681
- Acronym / sponsor ID
- HAMMER / THOR-707-101 (TCD16843)
- Conditions
- Metastasis
- Keywords
- Synthorx, THOR-707, THOR 707, Interleukin 2, Interleukin-2, IL2, oncology, immuno-oncology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated as per Sponsor decision. The decision was not related to any safety concerns.
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Synthorx, Inc, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- Evaluate the safety and tolerability of THOR-707 as a single agent and as a combination therapy (identify Dose Limiting Toxcitiy (DLTs) in Cohorts A, B, C, D, and G, and adverse events (AEs)/serious adverse event (SAE) profile in Cohorts A, B, C, D, E, F, and G)
- Define the Maximium Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of THOR-707 as a single agent and as a combination therapy (Cohorts A, B, C, D, and G)
- Evaluate preliminary anti-tumor activity of THOR-707 as a single agent by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohort H only)
Secondary Objectives:
- Evaluate preliminary anti-tumor activity of THOR-707 as a single agent and as a combination therapy by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohorts A, B, C, D, E, F, and G)
- Determine time to response (TTR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and clinical benefit rate (CBR) of THOR-707 as a single agent and as a combination therapy
- Evaluate the safety and tolerability of THOR-707 monotherapy QW/Q2W (AE/serious adverse event [SAE] profile) (Cohort H only).
Detailed description
The study duration per participant is approximately 24 months (inclusive of follow-up). Cohorts A, B, C, and D have been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort A-THOR-707 Q2W Monotherapy (Dose Escalation) | Experimental | Drug: THOR-707Subjects with advanced or metastatic solid tumors will receive THOR-707 in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W) until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Cohort B-THOR-707 Q3W Monotherapy (Dose Escalation) | Experimental | Drug: THOR-707Subjects with advanced or metastatic solid tumors will receive THOR-707 in sequential ascending doses as a monotherapy via IV administration every 3 weeks (Q3W) until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Cohort C-THOR-707 Q3W with checkpoint inhibitor (Dose Escalation) | Experimental | Drug: THOR-707, Drug: Checkpoint inhibitorSubjects with advanced or metastatic solid tumors will receive THOR-707 Q3W in sequential ascending doses in combination with a checkpoint inhibitor Q3W or every 6 weeks (Q6W) via IV administration until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Cohort D-THOR-707 Q3W with anti-EGFR antibody (Dose Escalation) | Experimental | Drug: THOR-707, Drug: anti-EGFR antibodySubjects with advanced or metastatic solid tumors will receive THOR-707 Q3W in sequential ascending doses in combination with an anti-EGFR antibody weekly dosing (QW) via IV administration until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Cohort E-THOR-707 Q2W with checkpoint inhibitor (Dose Expansion) | Experimental | Drug: THOR-707, Drug: Checkpoint inhibitorSubjects with advanced or metastatic solid tumors will receiveTHOR-707 Q2W at recommended Phase 2 dose (RP2D) with a checkpoint inhibitor via IV administration Q6W; it will consist of one 8-week cycle of THOR-707 monotherapy on Cycle 1 Day 1 followed by THOR-707 Q2W + checkpoint inhibitor Q6W starting at Cycle 1 Day 15. Subsequently treatment will consist of repeated 6-week cycles with combination therapy. |
| Cohort F-THOR-707 Q3W with checkpoint inhibitor (Dose Expansion) | Experimental | Drug: THOR-707, Drug: Checkpoint inhibitorSubjects with advanced or metastatic solid tumors will receive THOR-707 Q3W at recommended Phase 2 dose (RP2D) with a checkpoint inhibitor via IV administration Q6W will consist of one 9-week cycle of THOR monotherapy on Cycle 1 Day 1 followed by THOR-707 Q3W + checkpoint inhibitor at Cycle 1 Day 22. Subsequently treatment will consist of repeated 6-weeks cycles with combination therapy. |
| Cohort G Monotherapy QW/Q2W (Dose Escalation) | Experimental | Drug: THOR-707Subjects with advanced or metastatic solid tumors will receive THOR707 monotherapy QW for 6 weeks (induction period), and then every Q2W (maintenance period), which is referred as QW/Q2W thereafter, until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Cohort H Monotherapy QW/Q2W (Dose Expansion) | Experimental | Drug: THOR-707Subjects with late-line metastatic melanoma will receive THOR707 monotherapy at RP2D for Cohort G. Cycle 1 will consist of THOR-707 QW for 6 weeks; Cycle 2 and beyond will consist of THOR-707 Q2W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Measurable disease per RECIST v1.1. For Cohort G participants must have at least 1 measurable lesion, and for Part 3 (Cohorts E, F and H) participants must have at least 2 measurable lesions to safely perform mandatory pre \& on-treatment biopsy.
- Life expectancy greater than or equal to 12 weeks.
- For Part 2 exclusively: While it is highly preferred to enroll subjects who are naïve to PD-1 inhibitors into a Part 2 dose escalation cohort, this is not an enrollment requirement. However, subjects who enroll into a Part 2 safety expansion cohort must be naïve to PD-1 inhibitors. If such subject is unable to meet this requirement but otherwise remains a good candidate for study enrollment, the Investigator should discuss with the Sponsor whether the subject may be enrolled.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate cardiovascular, hematological, liver, and renal function.
Key exclusion criteria (27 listed)
- Radiotherapy ≤ 14 days prior to first dose of study drug (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment).
- Treated with systemic anti-cancer therapy or an investigational agent within 2 weeks prior to start of study drug treatment (within 4 weeks for immunotherapy and tyrosine kinase inhibitor therapy).
- Subjects who experienced Grade 3 or higher immune-related toxicity from prior immuno-oncology therapy.
- Major surgery ≤ 30 days prior to first dose of study drug, or has not recovered to at least Grade 1 from adverse effects from such procedure, or anticipation of the need for major surgery during study treatment.
- Active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THOR-707Also: SAR444245, PegenzileukinPharmaceutical form: solution for intravenous (IV) administration; Route of administration: IV administration | Drug | Cohort A-THOR-707 Q2W Monotherapy (Dose Escalation), Cohort B-THOR-707 Q3W Monotherapy (Dose Escalation), Cohort C-THOR-707 Q3W with checkpoint inhibitor (Dose Escalation), Cohort D-THOR-707 Q3W with anti-EGFR antibody (Dose Escalation), Cohort E-THOR-707 Q2W with checkpoint inhibitor (Dose Expansion), Cohort F-THOR-707 Q3W with checkpoint inhibitor (Dose Expansion), Cohort G Monotherapy QW/Q2W (Dose Escalation), Cohort H Monotherapy QW/Q2W (Dose Expansion) |
| Checkpoint inhibitorAlso: pembrolizumabPharmaceutical form: solution for IV administration; Route of administration: IV administration | Drug | Cohort C-THOR-707 Q3W with checkpoint inhibitor (Dose Escalation), Cohort E-THOR-707 Q2W with checkpoint inhibitor (Dose Expansion), Cohort F-THOR-707 Q3W with checkpoint inhibitor (Dose Expansion) |
| anti-EGFR antibodyAlso: cetuximabPharmaceutical form: solution for IV administration; Route of administration: IV administration | Drug | Cohort D-THOR-707 Q3W with anti-EGFR antibody (Dose Escalation) |
Primary outcome
Rate of Dose-Limiting Toxicities (DLTs)- Cohorts A, B, C, and D
Time frame: Study Day 1 up to Day 29
Based on toxicities observed
Maximum Tolerated Dose (MTD)- Cohorts A, B, C, and D
Time frame: Study Day 1 up to Day 29
Based on toxicities observed
Recommended Phase 2 Dose (RP2D)- Cohorts A, B, C, and D
Time frame: Study Day 1 up to Day 29
Based on toxicities observed
Number of participants with treatment emergent adverse events, serious adverse events, and laboratory abnormalities - Cohorts A, B, C, D, E, F, and G
Time frame: Study Day 1 up to approximately 24 months
Safety will be assessed by monitoring adverse events, clinical laboratory evaluations, vital signs, and ECG parameters.
Rate of Dose-Limiting Toxicities (DLTs) -Cohort G
Time frame: Study Day 1 up to Day 42 (6 week-cycle)
Based on toxicities observed
Recommended Phase 2 Dose (RP2D) of THOR-707- Cohort G
Time frame: Study Day 1 up to Day 42 (6 week-cycle)
Based on toxicities observed
Maximum Tolerated Dose (MTD)- Cohort G
Time frame: Study Day 1 up to Day 42 (6 week-cycle)
Based on toxicities observed
Objective Response Rate (ORR) according to RECIST version 1.1 -Cohort H
Time frame: Study Day 1 up to approximately 24 months
ORR, defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.
8 secondary outcomes
Objective Response Rate (ORR) according to RECIST version 1.1 Cohort A, B, C, D, E, F, and G)
Time frame: Study Day 1 up to approximately 24 months
Duration of Response (DOR) according to RECIST version 1.1
Time frame: Study Day 1 up to approximately 24 months
Progression-Free Survival (PFS) according to RECIST version 1.1
Time frame: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Overall Survival according to RECIST version 1.1
Time frame: Study Day 1 up to time of death, assessed up to approximately 24 months
Time to Response (TTR) according to RECIST version 1.1
Time frame: Study Day 1 up to approximately 24 months
Disease Control Rate (DCR) according to RECIST version 1.1
Time frame: Study Day 1 up to approximately 24 months
Clinical Benefit Rate (CBR)
Time frame: Study Day 1 up to approximately 24 months
Number of participants with treatment emergent adverse events, serious adverse events, laboratory abnormalities -Cohort H
Time frame: Study Day 1 up to approximately 24 months
Results and safety
The study was stopped early (reason given: The study was terminated as per Sponsor decision. The decision was not related to any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- TCD16843 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing THOR-707, Checkpoint inhibitor and anti-EGFR antibody in people with Metastasis, run by Synthorx, Inc, a Sanofi company at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Spain, United States, Australia, Chile, Singapore and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated as per Sponsor decision. The decision was not related to any safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Dose-Limiting Toxicities (DLTs)- Cohorts A, B, C, and D (time frame: Study Day 1 up to Day 29). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.