Clinical trial · Interventional
Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHS-006, as Monotherapy and in Combination With Toripalimab, in Participants With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated for strategic reasons (not for safety concerns)
Summary
Brief summary (as posted)
This phase 1 open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CHS-006 in combination with toripalimab in 2 phases. Phase 1 (Dose Optimization phase) will explore 2 different dose combinations in participants with advanced/metastatic solid tumors (except pancreatic) and Phase 2 (Indication-specific Expansion phase) will use one selected dose in specific tumor types (non-small cell lung cancer-non squamous \[NSCLC-NS\] and Hepatocellular carcinoma \[HCC\])
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHS-006 (anti-TIGIT) | Drug | — | UNRESOLVED |
| toripalimab (anti-PD-1) | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Dose Optimization Phase - Arm A
- description
- Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W
- interventionNames
- Drug: CHS-006 (anti-TIGIT)
- Drug: toripalimab (anti-PD-1)
- type
- ACTIVE_COMPARATOR
- label
- Dose Optimization Phase - Arm B
- description
- Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W
- interventionNames
- Drug: CHS-006 (anti-TIGIT)
- Drug: toripalimab (anti-PD-1)
- type
- ACTIVE_COMPARATOR
- label
- Indication-specific Expansion Phase - Cohort 1 NSCLC-NS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females, ≥18 years old; * Histopathologically or cytologically confirmed advanced solid tumor (except pancreatic) with disease progression after at least 1 prior line of standard therapy (Dose Optimization phase); * Tumor-specific criteria (Indication-specific Expansion phase): * NSCLC-NS (without sensitizing EGFR/ALK/ROS-1/MET mutations) 2nd line plus (2L+): has received and progressed on at least 1 prior chemotherapy regimen. Prior treatment with both anti-PD-1 therapy and platinum-based chemotherapy either concurrently or sequentially are eligible. * Hepatocellular carcinoma (HCC) 2L+: has received and progressed on at least 1 prior anticancer regimen. Participants with prior treatment with an anti-PD-1 or PD-L1 agent are eligible. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and expected survival ≥12 weeks; * At least 1 measurable lesion per RECIST v1.1; * Adequate organ and marrow function Exclusion Criteria: * Current or prior use of systemic anticancer therapy, including but not limited to chemotherapy, immunotherapy, biologic therapy, hormone therapy, and targeted therapy, within 28 days prior to the 1st dose of CHS-006; * NSCLC participants with genomic mutations (e.g., EGFR, ALK, ROS-1, MET, etc.) for which FDA-approved targeted therapies are available or require progression on appropriate prior to enrollment; * Prior exposure to monoclonal antibodies (mAbs) targeting TIGIT or any of its ligands, including CD155, CD112, or CD113; * Major surgery within 28 days prior to the 1st dose of CHS-006 or still recovering from prior surgery; * Symptomatic or untreated central nervous system (CNS) metastases; * Use of therapeutic immunosuppressive medication within 28 days prior to the 1st planned dose of CHS-006; * Receipt of live, attenuated vaccination within 30 days prior to the 1st dose of CHS- 006; * History of active autoimmune disease within the past 2 years, with the following exceptions: vitiligo, alopecia, endocrinopathies controlled by hormone replacement therapy, rheumatoid arthritis and other arthropathies that have not required immunosuppression other than nonsteroidal anti-inflammatory agents, celiac disease controlled by diet, or psoriasis controlled with topical medication; * Participants with another active solid tumor that has not been curatively treated.
References
Publications (0)
Data not yet available