Solid TumorPhase 1NCT05162755
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers
A Phase 1 study testing S095029 and S95029 and Sym021 in people with Solid Tumor, run by Institut de Recherches Internationales Servier at 5 sites in 2 countries.
Trial summary
The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- S095029 and S95029 and Sym021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Oct 2021to 5 May 2026
- 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
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies
- Patients with a malignancy not amenable to surgical intervention
- Patients with measurable disease and progression radiologically assessed
- Patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment.
- Patients with available archived tumor biopsy specimens or agree to mandatory biopsy
- Estimated life expectancy ≥ 12 weeks
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- Adequate haematological function
- Adequate renal function
- Adequate hepatic function
Who cannot join
- Pregnant and lactating women
- Major surgery within 4 weeks prior to the first IMP administration or not recovered from the surgery
- Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration
- Active Hepatitis B Virus infection
- Carriers of HIV antibodies
- Patients with active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration
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- History of organ transplantation
- History of gastrointestinal perforation, or intra-abdominal abscess within 28 days of inclusion
- History of cirrhosis
- History of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition
- Treatment with systemic immunosuppressive therapy
- Active autoimmune disease
- Administration of a live vaccine within 28 days prior to inclusion
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
START Midwest
Grand Rapids, Michigan, 49546
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
The START Center for Cancer Care
San Antonio, Texas, 78229
About this study
Official title: A Phase 1a/1b, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Anti-neoplastic Activity of S095029 (Anti-NKG2A) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triplet Combinations of S095029 and Sym021 and an Anti-HER2 mAb or Anti-EGFR mAbs (Futuximab/Modotuximab) in Patients With Metastatic Gastric or Colorectal Cancers
The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations.
*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.
- Conditions
- Solid Tumor
- Being tested
- S095029, S95029 and Sym021
- Keywords
- Adults, Advanced solid tumors, Sym21, Futuximab/modotuximab, Triplet combination, Anti-EGFR, Anti-HER2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S095029Drug
S095029 will be administered via IV infusion every 2 weeks. Once the DLT evaluations period at the second dose level is completed and it is deemed as safe, the dose escalation part 1b will be initiated.
S95029 and Sym021Drug
Sym021 will be administered at a fixed dose of 200mg. S095029 will be administered via IV infusion every 2 weeks. Once the RP2D dose of S95029 in combination with Sym21 is defined, dose expansion will begin.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation 1a: S95029 | Experimental | Not described Receives: Drug: S095029 |
| Dose escalation 1b: S95029 and Sym021 | Experimental | Not described Receives: Drug: S95029 and Sym021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) (Dose escalation part)
Incidence, severity, and relationship of AEs
Measured: Through study completion, up to 2 years
Incidence of dose limiting toxicities (DLTs) (Dose escalation part)
DLTs observed during a 28-day period
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (5)
Objective Response Rate
Measured: Through study completion, up to 2 years
Clinical Benefit Rate (CBR)
Assessment based on complete response, partial response and stable disease ≥ 6 months
Measured: Through study completion, up to 2 years
Duration of response (DOR)
Measured: Through study completion, up to 2 years
Progression Free Survival (PFS)
Measured: Through study completion, up to 2 years
Overall Survival (OS)
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start15 Oct 2021
- Primary completion1 Feb 2024
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
- Investigators
- Nehal Lakhani MD, MD, PhD, Principal investigator, Director of Clinical Research START Midwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162755
- Sponsor's protocol ID
- CL1-95029-001
- Status last verified
- May 2026
- First submitted
- 14 Oct 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Publications
Naing A, Spreafico A, Barve M, Patnaik A, Ianopoulos X, Drean P, Skartved NJ, Hemon A, Kantari-Mimoun C, He P, Askoxylakis V, Lakhani N. Phase 1 multicenter study of the NKG2A targeting antibody S095029 as a single agent and in combination with anti-PD-1 in patients with advanced malignancies. J Immunother Cancer. 2026 May 8;14(5):e014325. doi: 10.1136/jitc-2025-014325.
PubMed 42103356
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Anti-neoplastic Activity of S095029 (Anti-NKG2A) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triplet Combinations of S095029 and Sym021 and an Anti-HER2 mAb or Anti-EGFR mAbs (Futuximab/Modotuximab) in Patients With Metastatic Gastric or Colorectal Cancers
- ClinicalTrials.gov ID
- NCT05162755
- Acronym / sponsor ID
- CL1-95029-001
- Conditions
- Solid Tumor
- Keywords
- Adults, Advanced solid tumors, Sym21, Futuximab/modotuximab, Triplet combination, Anti-EGFR, Anti-HER2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 17 Dec 2021 (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 purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations.
*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation 1a: S95029 | Experimental | Drug: S095029 |
| Dose escalation 1b: S95029 and Sym021 | Experimental | Drug: S95029 and Sym021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies
- Patients with a malignancy not amenable to surgical intervention
- Patients with measurable disease and progression radiologically assessed
- Patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment.
- Patients with available archived tumor biopsy specimens or agree to mandatory biopsy
Key exclusion criteria (13 listed)
- Pregnant and lactating women
- Major surgery within 4 weeks prior to the first IMP administration or not recovered from the surgery
- Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration
- Active Hepatitis B Virus infection
- Carriers of HIV antibodies
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 |
|---|---|---|
| S095029S095029 will be administered via IV infusion every 2 weeks. Once the DLT evaluations period at the second dose level is completed and it is deemed as safe, the dose escalation part 1b will be initiated. | Drug | Dose escalation 1a: S95029 |
| S95029 and Sym021Sym021 will be administered at a fixed dose of 200mg. S095029 will be administered via IV infusion every 2 weeks. Once the RP2D dose of S95029 in combination with Sym21 is defined, dose expansion will begin. | Drug | Dose escalation 1b: S95029 and Sym021 |
Primary outcome
Adverse Events (AEs) (Dose escalation part)
Time frame: Through study completion, up to 2 years
Incidence, severity, and relationship of AEs
Incidence of dose limiting toxicities (DLTs) (Dose escalation part)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
DLTs observed during a 28-day period
5 secondary outcomes
Objective Response Rate
Time frame: Through study completion, up to 2 years
Clinical Benefit Rate (CBR)
Time frame: Through study completion, up to 2 years
Duration of response (DOR)
Time frame: Through study completion, up to 2 years
Progression Free Survival (PFS)
Time frame: Through study completion, up to 2 years
Overall Survival (OS)
Time frame: Through study completion, up to 2 years
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 12 May 2026.
- Derived from this study: PubMed 42103356Naing A, Spreafico A, Barve M, Patnaik A, Ianopoulos X, Drean P, Skartved NJ, Hemon A, Kantari-Mimoun C, He P, Askoxylakis V, Lakhani N. Phase 1 multicenter study of the NKG2A targeting antibody S095029 as a single agent and in combination with anti-PD-1 in patients with advanced malignancies. J Immunother Cancer. 2026 May 8;14(5):e014325. doi: 10.1136/jitc-2025-014325.
- Find Results on Servier Clinical Trial Data websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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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.
Nehal Lakhani MD, MD, PhD principal investigator
Director of Clinical Research START Midwest
5 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 S095029 and S95029 and Sym021 in people with Solid Tumor, run by Institut de Recherches Internationales Servier at 5 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 9 inclusion and 13 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Adverse Events (AEs) (Dose escalation part) (time frame: Through study completion, up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05162755, which also lists 1 linked publication.
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 12 May 2026.