A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors

NCT06963502
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Phase
Phase 1
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Recruitment status
Not yet recruiting
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Participants
762
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Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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Start date
2025-05-30
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Number of sites
2
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Summary
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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Short title
A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
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Official title
A Phase Ib Study Evaluating the Safety, Tolerability , Pharmacokinetics，Activity and Immunogenicity of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-04-30
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First posted
2025-05-09
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Registry last updated
2025-05-09
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Primary completion date
2028-12-31
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Start date
2025-05-30
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Participants
762
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Participant count basis
Estimated
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Planned participants
762
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Protocol amendments
0
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Number of sites
2
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06963502
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ClinicalTrials.gov ID
NCT06963502
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants with Adverse Event(s) (AEs)

    Timeframe: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).

    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)

  1. Overall Response Rate (ORR)

    Timeframe: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).

    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

  2. Disease Control Rate (DCR)

    Timeframe: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).

    Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD).DCR by the Investigator According to RECIST v1.1

  3. Time to Response (TTR)

    Timeframe: 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).

    TTR by the Investigator According to RECIST v1.1

  4. Duration of Response (DOR)

    Timeframe: Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years

    DOR by the Investigator According to RECIST v1.1

  5. Progression-Free Survival (PFS)

    Timeframe: Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years

    PFS by the Investigator According to RECIST v1.1

  6. Overall survival (OS)

    Timeframe: Cycle 1 Day 1 to date of death from any cause, up to 5 years (each cycle is 14 days)

    Defined as the time from C1D1 to death from any cause by the Investigator According to RECIST v1.1

  7. Plasma Concentrations of HS-10370

    Timeframe: 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)

    Defined as the time from C1D1 to death from any cause

  8. Maximum plasma concentration (Cmax)

    Timeframe: 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)

    Cmax is defined as maximum observed serum concentration obtained directly from the observed concentration-time data.

  9. Time of maximum concentration (Tmax)

    Timeframe: 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)

    Tmax is defined as the time required for a drug to reach peak concentration in plasma.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.
  • Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.
  • Documentation of the presence of a KRAS G12C mutation
  • 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.Men also consent to use adequate contraceptive method within the same time limit.
  • The subjects are able to comply with the process of the protocol.

  • Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
  • 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
  • Uncontrolled hypertension.
  • Severe bleeding symptoms or bleeding tendencies.
  • Severe arteriovenous thrombosis occurred
  • Serious infection.
  • Continuous use of glucocorticoids
  • Active infectious diseases.
  • Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
  • Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis.
  • Interstitial lung disease (ILD).
  • Serious neurological or mental disorders.
  • Active autoimmune diseases
Sources for eligibility
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  • The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, China
  • Sun Yat-sen University Cancer CenterShanghai, China
Sources for sites
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Related records

Drugs (7)

Lead sponsors (1)

Conditions (3)

Targets (3)