Clinical trial · Interventional
Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors
Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial
NCT06621563CI-TRIAL-00088364HS-20117recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-20117+CAPEOX | Drug | — | UNRESOLVED |
| HS-20117 combined HS-20093 | Drug | — | UNRESOLVED |
| HS-20117 combined HS-20093 and 5-FU | Drug | — | UNRESOLVED |
| HS-20117 combined Platinum-containing chemotherapy | Drug | — | UNRESOLVED |
| HS-20117+FOLFIRI | Drug | — | UNRESOLVED |
| HS-20117+mFOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1a
- description
- NSCLC
- interventionNames
- Drug: HS-20117 combined Platinum-containing chemotherapy
- type
- EXPERIMENTAL
- label
- Cohort 2a
- description
- NSCLC
- interventionNames
- Drug: HS-20117 combined HS-20093
- type
- EXPERIMENTAL
- label
- Cohort 3a
- description
- CRC
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females aged 18 - 75 years (inclusive). * Histologically confirmed unresectable, recurrent or metastatic solid tumors. * At least one target lesion per the RECIST v1.1. * ECOG performance status of 0-1. * Minimum life expectancy \> 12 weeks. * Males or Females should be using adequate contraceptive measures throughout the study. * Females must not be pregnant at screening or have evidence of non-childbearing potential. * Signed Informed Consent Form. Exclusion Criteria: * Received or are receiving the following treatments: 1. Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates. 2. Monoclonalor bispecific antibodies targeting EGFR. 3. Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117. 4. Investigational anti-cancer drugs or antibodies or ADCs within 4 weeks prior to the first dose of HS-20117. 5. Local radiotherapy within 2 weeks prior to the first dose of HS-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of HS-20117. 6. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion. 7. Major surgery within 4 weeks prior to the first dose of HS-20117. * Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy. * Presence of uncured secondary primary malignancies. * Untreated, or active central nervous system metastases. * Severe, uncontrolled or active cardiovascular disorders. * Serious infection within 4 weeks prior to the first dose of HS-20117.
References
Publications (0)
Data not yet available
No reference posted for this study.