Metastatic CancerPhase 1NCT03311412
Sym021 Monotherapy, in Combination With Sym022 or Sym023, and in Combination With Both Sym022 and Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas
A Phase 1 study testing Sym021, Sym022 and Sym023 in people with Metastatic Cancer and Solid Tumor, run by Symphogen A/S at 4 sites in 2 countries.
Trial summary
The primary purpose of this study is to see if Sym021 is safe and tolerable as monotherapy, in combination with either Sym022 or Sym023, and in Combination with both Sym022 and Sym023 for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Solid Tumor, Lymphoma
- What is being tested?
- Sym021, Sym022 and Sym023
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Nov 2017to 23 Mar 2022
- Phase
- Phase 1
- 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
- Male or female patients, ≥ 18 years of age at the time of obtaining informed consent.
- Documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; patients with documented lymphoma.
- Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
- Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit.
- Measurable or non-measurable disease according to RECIST v1.1 or RECIL 2017.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Persons of childbearing potential agreeing to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug(s); men agreeing to refrain from sperm donation during this period.
Who cannot join
- Women who are pregnant or intending to become pregnant before, during, or within 6 months after the last dose of study drug; women who are breastfeeding; persons of childbearing potential and not willing to use a highly effective method of contraception.
- Central nervous system (CNS) malignancies; patients with known, untreated CNS or leptomeningeal metastases, or spinal cord compression, patients with any of the above not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
- Hematologic malignancies other than lymphoma.
- Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to Cycle 1/Day 1 (C1/D1) unless adequately treated and considered stable.
- Active uncontrolled bleeding or a known bleeding diathesis.
- Clinically significant cardiovascular disease or condition.
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- Significant ocular disease or condition, including history of an autoimmune or inflammatory disorder.
- Significant pulmonary disease or condition.
- Current or recent (within 6 months) significant gastrointestinal (GI) disease or condition.
- An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
- History of organ transplantation (e.g., stem cell or solid organ transplant).
- History of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapy.
- Patients with unresolved > Grade 1 toxicity associated with any prior antineoplastic therapy except for persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, lymphopenia, hypomagnesemia, and/or end-organ failure being adequately managed by hormone replacement therapy.
- Inadequate recovery from any prior surgical procedure, or having undergone any major surgical procedure within 4 weeks prior to C1/D1.
- Known history of human immunodeficiency virus (HIV) or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Drugs and Other Treatments Exclusion Criteria:
- Part 2 Combination Dose-Escalations ONLY: Prior therapy with:
- Sym021 or other inhibitors of PD-1/PD-L1.
- Sym022 or other inhibitors of LAG-3, if participating in Arm A.
- Sym023 or other inhibitors of TIM-3, if participating in Arm B.
- Part 3 Combination Dose-Escalations ONLY: Prior therapy with:
- Sym022 or other inhibitors of LAG-3
- Sym023 or other inhibitors of TIM-3
- Any antineoplastic agent for the primary malignancy (standard or investigational) within 4 weeks or 5 plasma half-lives, whichever is shortest, prior to first study drug administration and during study, with exceptions.
- Any other investigational treatments within 2 weeks prior to and during study; includes participation in any medical device or supportive care therapeutic intervention trials.
- Radiotherapy, with exceptions.
- Use of live vaccines against infectious diseases 4 weeks prior to first study drug administration and during study.
- Immunosuppressive or systemic hormonal therapy within 2 weeks prior to first study drug administration and during study, with exceptions.
- Prophylactic use of hematopoietic growth factors within 1 week prior to first study drug administration and during Cycle 1 of study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49503
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology
San Antonio, Texas, 78240
About this study
Official title: A Phase 1, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of Sym021 (Anti-PD-1) as Monotherapy, in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3), and in Combination With Both Sym022 and Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas
The primary purpose of this study is to see if Sym021 is safe and tolerable as monotherapy, in combination with either Sym022 or Sym023, and in Combination with both Sym022 and Sym023 for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.
Read the detailed description
Part 1 of this study will evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) to establish the maximum tolerated dose (MTD) and/or the selected dose of sequential escalating doses of Sym021 when administered once every 2 weeks (Q2W) by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available
Part 2 of the study will evaluate the safety, tolerability, and DLTs to establish the MTD and/or the selected dose of sequential escalating doses of Sym022 when administered Q2W in combination with a fixed dose of 3 mg/kg of Sym021, each by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available
Part 3 of the study will evaluate of the safety, tolerability, and DLTs to establish the MTD and/or the selected dose of sequential escalating doses of Sym023 when administered Q2W in combination with fixed doses of 3 mg/kg of Sym021 and either 1, 3 or 5 mg/kg of Sym022, each by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.
- Conditions
- Metastatic Cancer, Solid Tumor, Lymphoma
- Being tested
- Sym021, Sym022, Sym023
- Keywords
- Locally advanced/unresectable, Metastatic solid tumor, Lymphoma, Anti-PD-1, PD-1, PD1, Anti-LAG-3, LAG-3, LAG3, Anti-TIM-3, TIM-3, TIM3
- Medical subject headings
- Neoplasm Metastasis, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sym021Drug
Also called Anti-PD-1
Sym021 is a humanized antibody that binds PD-1 with sub-nanomolar affinity and blocks binding of the inhibitory ligands PD-L1 and PD-L2, thus releasing PD-1-mediated inhibition of the immune response.
Sym022Drug
Also called Anti-LAG-3
Sym022 is a recombinant, fully human antibody that binds LAG-3 and blocks the LAG-3/major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production.
Sym023Drug
Also called Anti-TIM-3
Sym023 is a recombinant, fully human antibody that binds TIM-3 and induces activation of immune cells.
| Study group | Role | What they receive |
|---|---|---|
| Sym021 Dose Level 1 | Experimental | Part 1, Sym021 monotherapy dose level 1 Receives: Drug: Sym021 |
| Sym021 Dose Level 2 | Experimental | Part 1, Sym021 monotherapy dose level 2 Receives: Drug: Sym021 |
| Sym021 Dose Level 3 | Experimental | Part 1, Sym021 monotherapy dose level 3 Receives: Drug: Sym021 |
| Arm A: Sym021+Sym022 Dose Level 1 | Experimental | Part 2, Arm A: Sym021 RP2D in combination with dose level 1 of Sym022 Receives: Drug: Sym021; Drug: Sym022 |
| Arm A: Sym021+Sym022 Dose Level 2 | Experimental | Part 2, Arm A: Sym021 RP2D in combination with dose level 2 of Sym022 Receives: Drug: Sym021; Drug: Sym022 |
| Arm A: Sym021+Sym022 Dose Level 3 | Experimental | Part 2, Arm A: Sym021 RP2D in combination with dose level 3 of Sym022 Receives: Drug: Sym021; Drug: Sym022 |
| Arm A: Sym021+Sym022 Dose Level 4 | Experimental | Part 2, Arm A: Sym021 RP2D in combination with dose level 4 of Sym022 Receives: Drug: Sym021; Drug: Sym022 |
| Arm B: Sym021+Sym023 Dose Level 1 | Experimental | Part 2, Arm B: Sym021 RP2D in combination with dose level 1 of Sym023 Receives: Drug: Sym021; Drug: Sym023 |
| Arm B: Sym021+Sym023 Dose Level 2 | Experimental | Part 2, Arm B: Sym021 RP2D in combination with dose level 2 of Sym023 Receives: Drug: Sym021; Drug: Sym023 |
| Arm B: Sym021+Sym023 Dose Level 3 | Experimental | Part 2, Arm B: Sym021 RP2D in combination with dose level 3 of Sym023 Receives: Drug: Sym021; Drug: Sym023 |
| Arm B: Sym021+Sym023 Dose Level 4 | Experimental | Part 2, Arm B: Sym021 RP2D in combination with dose level 4 of Sym023 Receives: Drug: Sym021; Drug: Sym023 |
| Arm B: Sym021+Sym023 Dose Level 5 | Experimental | Part 2, Arm B: Sym021 RP2D in combination with dose level 5 of Sym023 Receives: Drug: Sym021; Drug: Sym023 |
| Sym021+Sym022+Sym023 Dose Level 1 | Experimental | Part 3, Sym021 in combination with Sym022 and Sym023 Receives: Drug: Sym021; Drug: Sym022; Drug: Sym023 |
| Sym021+Sym022+Sym023 Dose Level 2 | Experimental | Part 3, Sym021 in combination with Sym022 and Sym023 Receives: Drug: Sym021; Drug: Sym022; Drug: Sym023 |
| Sym021+Sym022+Sym023 Dose Level 3 | Experimental | Part 3, Sym021 in combination with Sym022 and Sym023 Receives: Drug: Sym021; Drug: Sym022; Drug: Sym023 |
| Sym021+Sym022+Sym023 Dose Level 4 | Experimental | Part 3, Sym021 in combination with Sym022 and Sym023 Receives: Drug: Sym021; Drug: Sym022; Drug: Sym023 |
| Sym021+Sym022+Sym023 Dose Level 5 | Experimental | Part 3, Sym021 in combination with Sym022 and Sym023 Receives: Drug: Sym021; Drug: Sym022; Drug: Sym023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Assess the safety and tolerability of Sym021 monotherapy on a Q2W schedule. Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1.
Measured: 12 months
Part 2: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Assess the safety and tolerability of the Sym021 RP2D in combination with sequential escalating doses of Sym022 or Sym023 on a Q2W schedule. Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1.
Measured: 12 months
Part 3: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Assess the safety and tolerability of the Sym021 RP2D in combination with sequential escalating doses of Sym022 and Sym023 on a Q2W schedule. Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1.
Measured: 12 months
Secondary outcomes (9)
Evaluation of the immunogenicity of Sym021 as a single agent and in combination with Sym022 and Sym023.
Serum sampling to assess the potential for anti-drug antibody (ADA) formation.
Measured: 24 months
Evaluation of objective response (OR) or stable disease (SD).
Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), Response Evaluation Criteria in Lymphomas 2017 (RECIL 2017), or Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST), depending on tumor type.
Measured: 24 months
Time to progression (TTP) of disease.
Based on time of enrollment to first evidence of progression on imaging studies, as assessed by RECIST v1.1, RECIL 2017, or iRECIST, depending on tumor type.
Measured: 24 months
Area under the concentration-time curve in a dosing interval (AUC)
Will be estimated using non-compartmental methods and actual timepoints.
Measured: 24 months
Maximum concentration (Cmax)
Will be derived from observed data.
Measured: 24 months
Time to reach maximum concentration (Tmax)
Will be derived from observed data.
Measured: 24 months
Trough concentration (Ctrough)
Will be derived from observed data.
Measured: 24 months
Terminal elimination half-life (T½)
Will be estimated using non-compartmental methods and actual timepoints.
Measured: 24 months
Clearance (CL)
Will be estimated using non-compartmental methods and actual timepoints.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start20 Nov 2017
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symphogen A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, FRCPC, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311412
- Sponsor's protocol ID
- Sym021-01
- Status last verified
- May 2023
- First submitted
- 3 Oct 2017
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of Sym021 (Anti-PD-1) as Monotherapy, in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3), and in Combination With Both Sym022 and Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas
- ClinicalTrials.gov ID
- NCT03311412
- Acronym / sponsor ID
- Sym021-01
- Conditions
- Metastatic Cancer, Solid Tumor, Lymphoma
- Keywords
- Locally advanced/unresectable, Metastatic solid tumor, Lymphoma, Anti-PD-1, PD-1, PD1, Anti-LAG-3, LAG-3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Symphogen A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 17 Oct 2017 (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.
The primary purpose of this study is to see if Sym021 is safe and tolerable as monotherapy, in combination with either Sym022 or Sym023, and in Combination with both Sym022 and Sym023 for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.
Detailed description
Part 1 of this study will evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) to establish the maximum tolerated dose (MTD) and/or the selected dose of sequential escalating doses of Sym021 when administered once every 2 weeks (Q2W) by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available
Part 2 of the study will evaluate the safety, tolerability, and DLTs to establish the MTD and/or the selected dose of sequential escalating doses of Sym022 when administered Q2W in combination with a fixed dose of 3 mg/kg of Sym021, each by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available
Part 3 of the study will evaluate of the safety, tolerability, and DLTs to establish the MTD and/or the selected dose of sequential escalating doses of Sym023 when administered Q2W in combination with fixed doses of 3 mg/kg of Sym021 and either 1, 3 or 5 mg/kg of Sym022, each by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Sym021 Dose Level 1 | Experimental | Drug: Sym021Part 1, Sym021 monotherapy dose level 1 |
| Sym021 Dose Level 2 | Experimental | Drug: Sym021Part 1, Sym021 monotherapy dose level 2 |
| Sym021 Dose Level 3 | Experimental | Drug: Sym021Part 1, Sym021 monotherapy dose level 3 |
| Arm A: Sym021+Sym022 Dose Level 1 | Experimental | Drug: Sym021, Drug: Sym022Part 2, Arm A: Sym021 RP2D in combination with dose level 1 of Sym022 |
| Arm A: Sym021+Sym022 Dose Level 2 | Experimental | Drug: Sym021, Drug: Sym022Part 2, Arm A: Sym021 RP2D in combination with dose level 2 of Sym022 |
| Arm A: Sym021+Sym022 Dose Level 3 | Experimental | Drug: Sym021, Drug: Sym022Part 2, Arm A: Sym021 RP2D in combination with dose level 3 of Sym022 |
| Arm A: Sym021+Sym022 Dose Level 4 | Experimental | Drug: Sym021, Drug: Sym022Part 2, Arm A: Sym021 RP2D in combination with dose level 4 of Sym022 |
| Arm B: Sym021+Sym023 Dose Level 1 | Experimental | Drug: Sym021, Drug: Sym023Part 2, Arm B: Sym021 RP2D in combination with dose level 1 of Sym023 |
| Arm B: Sym021+Sym023 Dose Level 2 | Experimental | Drug: Sym021, Drug: Sym023Part 2, Arm B: Sym021 RP2D in combination with dose level 2 of Sym023 |
| Arm B: Sym021+Sym023 Dose Level 3 | Experimental | Drug: Sym021, Drug: Sym023Part 2, Arm B: Sym021 RP2D in combination with dose level 3 of Sym023 |
| Arm B: Sym021+Sym023 Dose Level 4 | Experimental | Drug: Sym021, Drug: Sym023Part 2, Arm B: Sym021 RP2D in combination with dose level 4 of Sym023 |
| Arm B: Sym021+Sym023 Dose Level 5 | Experimental | Drug: Sym021, Drug: Sym023Part 2, Arm B: Sym021 RP2D in combination with dose level 5 of Sym023 |
| Sym021+Sym022+Sym023 Dose Level 1 | Experimental | Drug: Sym021, Drug: Sym022, Drug: Sym023Part 3, Sym021 in combination with Sym022 and Sym023 |
| Sym021+Sym022+Sym023 Dose Level 2 | Experimental | Drug: Sym021, Drug: Sym022, Drug: Sym023Part 3, Sym021 in combination with Sym022 and Sym023 |
| Sym021+Sym022+Sym023 Dose Level 3 | Experimental | Drug: Sym021, Drug: Sym022, Drug: Sym023Part 3, Sym021 in combination with Sym022 and Sym023 |
| Sym021+Sym022+Sym023 Dose Level 4 | Experimental | Drug: Sym021, Drug: Sym022, Drug: Sym023Part 3, Sym021 in combination with Sym022 and Sym023 |
| Sym021+Sym022+Sym023 Dose Level 5 | Experimental | Drug: Sym021, Drug: Sym022, Drug: Sym023Part 3, Sym021 in combination with Sym022 and Sym023 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients, ≥ 18 years of age at the time of obtaining informed consent.
- Documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; patients with documented lymphoma.
- Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
- Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit.
- Measurable or non-measurable disease according to RECIST v1.1 or RECIL 2017.
Key exclusion criteria (29 listed)
- Women who are pregnant or intending to become pregnant before, during, or within 6 months after the last dose of study drug; women who are breastfeeding; persons of childbearing potential and not willing to use a highly effective method of contraception.
- Central nervous system (CNS) malignancies; patients with known, untreated CNS or leptomeningeal metastases, or spinal cord compression, patients with any of the above not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
- Hematologic malignancies other than lymphoma.
- Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to Cycle 1/Day 1 (C1/D1) unless adequately treated and considered stable.
- Active uncontrolled bleeding or a known bleeding diathesis.
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 |
|---|---|---|
| Sym021Also: Anti-PD-1Sym021 is a humanized antibody that binds PD-1 with sub-nanomolar affinity and blocks binding of the inhibitory ligands PD-L1 and PD-L2, thus releasing PD-1-mediated inhibition of the immune response. | Drug | Arm A: Sym021+Sym022 Dose Level 1, Arm A: Sym021+Sym022 Dose Level 2, Arm A: Sym021+Sym022 Dose Level 3, Arm A: Sym021+Sym022 Dose Level 4, Arm B: Sym021+Sym023 Dose Level 1, Arm B: Sym021+Sym023 Dose Level 2, Arm B: Sym021+Sym023 Dose Level 3, Arm B: Sym021+Sym023 Dose Level 4, Arm B: Sym021+Sym023 Dose Level 5, Sym021 Dose Level 1, Sym021 Dose Level 2, Sym021 Dose Level 3, Sym021+Sym022+Sym023 Dose Level 1, Sym021+Sym022+Sym023 Dose Level 2, Sym021+Sym022+Sym023 Dose Level 3, Sym021+Sym022+Sym023 Dose Level 4, Sym021+Sym022+Sym023 Dose Level 5 |
| Sym022Also: Anti-LAG-3Sym022 is a recombinant, fully human antibody that binds LAG-3 and blocks the LAG-3/major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. | Drug | Arm A: Sym021+Sym022 Dose Level 1, Arm A: Sym021+Sym022 Dose Level 2, Arm A: Sym021+Sym022 Dose Level 3, Arm A: Sym021+Sym022 Dose Level 4, Sym021+Sym022+Sym023 Dose Level 1, Sym021+Sym022+Sym023 Dose Level 2, Sym021+Sym022+Sym023 Dose Level 3, Sym021+Sym022+Sym023 Dose Level 4, Sym021+Sym022+Sym023 Dose Level 5 |
| Sym023Also: Anti-TIM-3Sym023 is a recombinant, fully human antibody that binds TIM-3 and induces activation of immune cells. | Drug | Arm B: Sym021+Sym023 Dose Level 1, Arm B: Sym021+Sym023 Dose Level 2, Arm B: Sym021+Sym023 Dose Level 3, Arm B: Sym021+Sym023 Dose Level 4, Arm B: Sym021+Sym023 Dose Level 5, Sym021+Sym022+Sym023 Dose Level 1, Sym021+Sym022+Sym023 Dose Level 2, Sym021+Sym022+Sym023 Dose Level 3, Sym021+Sym022+Sym023 Dose Level 4, Sym021+Sym022+Sym023 Dose Level 5 |
Primary outcome
Part 1: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Time frame: 12 months
Assess the safety and tolerability of Sym021 monotherapy on a Q2W schedule. Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1.
Part 2: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Time frame: 12 months
Assess the safety and tolerability of the Sym021 RP2D in combination with sequential escalating doses of Sym022 or Sym023 on a Q2W schedule. Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1.
Part 3: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Time frame: 12 months
Assess the safety and tolerability of the Sym021 RP2D in combination with sequential escalating doses of Sym022 and Sym023 on a Q2W schedule. Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1.
9 secondary outcomes
Evaluation of the immunogenicity of Sym021 as a single agent and in combination with Sym022 and Sym023.
Time frame: 24 months
Evaluation of objective response (OR) or stable disease (SD).
Time frame: 24 months
Time to progression (TTP) of disease.
Time frame: 24 months
Area under the concentration-time curve in a dosing interval (AUC)
Time frame: 24 months
Maximum concentration (Cmax)
Time frame: 24 months
Time to reach maximum concentration (Tmax)
Time frame: 24 months
Trough concentration (Ctrough)
Time frame: 24 months
Terminal elimination half-life (T½)
Time frame: 24 months
Clearance (CL)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
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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.
Lillian Siu, MD, FRCPC principal investigator
Princess Margaret Cancer Centre
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sym021, Sym022 and Sym023 in people with Metastatic Cancer and Solid Tumor, run by Symphogen A/S at 4 sites in 2 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 7 inclusion and 29 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: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria. (time frame: 12 months). The study lists 3 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 30 May 2023.