A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Participants with KRAS G12C Mutation Advanced Solid Tumors
A Phase Ib Study Evaluating the Safety, Tolerability , Pharmacokinetics and Activity of HS-10370 in Addition to Other Anti-cancer Therapies in Participants with KRAS G12C Mutation Advanced Solid Tumors
1 other identifier
interventional
350
1 country
1
Brief Summary
This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics and Activity of HS-10370 in Combination With Other Anti-cancer Therapies in patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in non-Small cell lung cancer (NSCLC) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 nonsmall-cell-lung-cancer
Started Oct 2024
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
September 19, 2024
September 1, 2024
2 years
September 4, 2024
September 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 to first documented progression of disease or death from any cause, approximately 2 years.
Secondary Outcomes (9)
Overall Response Rate (ORR)
From Cycle 1 Day 1 (C1D1) to disease progression or death, approximately 2 years.
Disease Control Rate (DCR)
From C1D1 to disease progression or death, approximately 2 years.
Time to Response (TTR)
Time from C1D1 until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, approximately 2 years.
Duration of Response (DOR)
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)
Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years.
- +4 more secondary outcomes
Study Arms (5)
Arm A: HS-10370 dose 1 + Adebrelimab
EXPERIMENTALParticipants will receive HS-10370 dose 1 administered orally plus Adebrelimab given as a 20 mg/kg intravenous infusion(IV) once every 21-day cycle up to a total of 35 cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Arm B: HS-10370 dose 2 + Adebrelimab
EXPERIMENTALParticipants will receive HS-10370 dose 2 administered orally plus Adebrelimab given as a 20 mg/kg intravenous infusion(IV) once every 21-day cycle up to a total of 35 cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Arm C: HS-10370+ Adebrelimab + Pemetrexed and Platinum
EXPERIMENTALParticipants will receive HS-10370 administered orally in plus with Adebrelimab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met
Arm D: HS-10370+ Adebrelimab + Pemetrexed
EXPERIMENTALParticipants will receive HS-10370 administered orally in plus with Adebrelimab and pemetrexed administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Arm E: HS-10370+ Pemetrexed and Platinum
EXPERIMENTALParticipants will receive HS-10370 administered orally in plus with pemetrexed and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Interventions
HS-10370 administered orally every day
Administered intravenously every 21 days; dose by label.
Administered intravenously every 21 days; dose by label.
Administered intravenously every 21 days; dose by label.
Administered intravenously every 21 days; dose by label.
Eligibility Criteria
You may qualify if:
- Men or women greater than or equal to 18 years
- At least one measurable lesion in accordance with RECIST 1.1
- Must have an ECOG performance status of 0 or 1.
- Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
- Documentation of the presence of a KRAS G12C mutation
- Must provide tumor tissue sample
- No history of systemic anticancer therapy in metastatic/non-curable settings
- Estimated life expectancy ≥12 weeks.
- Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.
- Females must have the evidence of non-childbearing potential; Likewise, men also consent to use adequate contraceptive method within the same time limit.
- Signed and dated Informed Consent Form.
- The subjects are able to comply with the process of the protocol.
You may not qualify if:
- Treatment with any of the following:
- Previous or current treatment with other KRAS G12C inhibitors
- Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of study treatment; Any investigational agents and large molecule antibodies within 28 days of the first dose of study treatment.
- Local radiotherapy within 2 weeks prior to the first dose of study drug, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of study drug.
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose
- Active brain metastases.
- Patients with uncontrolled pleural, ascites or pericardial effusion
- Spinal cord compression
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- Subjects with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ functions.
- Abnormal cardiac examination results.
- Severe, uncontrolled or active cardiovascular disorders.
- Diabetes ketoacidosis or hyperglycemia hyperosmolality
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology
Wuhan, Hubei, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2024
First Posted
September 19, 2024
Study Start
October 31, 2024
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
September 19, 2024
Record last verified: 2024-09