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NCT Number: NCT06963502

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

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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Key information

Conditions

Advanced Solid Tumors Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

HS-10370

Drug

Participants will receive HS-10370 dose 1 administered orally

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.

Primary outcomes

  1. Number of Participants with Adverse Event(s) (AEs)

    Time frame: 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)

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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