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This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics, Activity and Immunogenicity of HS-10370 in Combination With Other Anti-cancer Therapies in Chinese patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in and Colorectal cancer(CRC) and non-Small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1:HS-10370 dose 1+ HS-20117 dose 3 | Experimental |
| |
| Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab | Experimental |
| |
| Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy | Experimental |
| |
| Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy | Experimental |
| |
| Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5 | Experimental |
| |
| Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10370 | Drug | Participants will receive HS-10370 dose 1 administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Event(s) (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) | From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).ORR by the Investigator According to RECIST v1.1 | From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days). |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
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| Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy | Experimental |
|
| HS-20117 | Drug | Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle. |
|
| Adebrelimab | Drug | Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle |
|
| Capecitabine | Drug | Participants will receive Capecitabine administered orally |
|
| Oxaliplatin | Drug | Participants will receive Oxaliplatin intravenous infusion(IV) once every 21-day cycle. |
|
| Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan | Drug | Participants will receive Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan intravenous infusion(IV) once every 14-day cycle. |
|
| HS-20093 | Drug | Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle |
|
| platinum (cisplatin or carboplatin) | Drug | Participants will receive platinum (cisplatin or carboplatin) administered IV in 21-day cycles. |
|
Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD).DCR by the Investigator According to RECIST v1.1 |
| From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days). |
| Time to Response (TTR) | TTR by the Investigator According to RECIST v1.1 | Time from Cycle 1 Day 1 until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, up to 2 years (each cycle is 14 days). |
| Duration of Response (DOR) | DOR by the Investigator According to RECIST v1.1 | Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years |
| Progression-Free Survival (PFS) | PFS by the Investigator According to RECIST v1.1 | Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years |
| Overall survival (OS) | Defined as the time from C1D1 to death from any cause by the Investigator According to RECIST v1.1 | Cycle 1 Day 1 to date of death from any cause, up to 5 years (each cycle is 14 days) |
| Plasma Concentrations of HS-10370 | Defined as the time from C1D1 to death from any cause | Cycle 1 Day 1 to date of death from any cause. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation, up to 2 years. (each cycle is 14 days) |
| Maximum plasma concentration (Cmax) | Cmax is defined as maximum observed serum concentration obtained directly from the observed concentration-time data. | Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days) |
| Time of maximum concentration (Tmax) | Tmax is defined as the time required for a drug to reach peak concentration in plasma. | Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days) |
| Sun Yat-sen University Cancer Center | Shanghai | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D010984 | Platinum |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D017606 | Chlorine Compounds |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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