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Advanced Solid TumorsPhase 1NCT06963502

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

A Phase 1 study testing HS-10370, HS-20117 and Adebrelimab in people with Advanced Solid Tumors and Colorectal Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HS-10370, HS-20117 and Adebrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
762 participants
Where
2 sitesChina
Study dates
30 May 2025to 30 Apr 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

    Xia Liu, (0086)0571-87783508, hrec2013@126.com

    Ying Yuan

  • Sun Yat-sen University Cancer Center

    Shanghai

    Xuzhi Pan, 020-87343009, llwyh@sysucc.org.cn

    Ruihua Xu

Other trials in China

About this study

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

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).

Being tested
HS-10370, HS-20117, Adebrelimab, Capecitabine, Oxaliplatin
Medical subject headings
Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10370Drug

    Participants will receive HS-10370 dose 1 administered orally

  • HS-20117Drug

    Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.

  • AdebrelimabDrug

    Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle

  • CapecitabineDrug

    Participants will receive Capecitabine administered orally

  • OxaliplatinDrug

    Participants will receive Oxaliplatin intravenous infusion(IV) once every 21-day cycle.

  • Folinic Acid, Fluorouracil and Oxaliplatin/IrinotecanDrug

    Participants will receive Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan intravenous infusion(IV) once every 14-day cycle.

  • HS-20093Drug

    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.

Study groups in NCT06963502
Study groupRoleWhat they receive
Arm 1:HS-10370 dose 1+ HS-20117 dose 3ExperimentalNot described
Receives: Drug: HS-10370; Drug: HS-20117
Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ AdebrelimabExperimentalNot described
Receives: Drug: HS-10370; Drug: HS-20117; Drug: Adebrelimab
Arm 3: HS-10370 dose 1 + HS-20117 dose4 + ChemotherapyExperimentalNot described
Receives: Drug: HS-10370; Drug: HS-20117; Drug: Capecitabine; Drug: Oxaliplatin
Arm 4: HS-10370 dose 1 + HS-20117 dose3 + ChemotherapyExperimentalNot described
Receives: Drug: HS-10370; Drug: HS-20117; Drug: Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan
Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5ExperimentalNot described
Receives: Drug: HS-10370; Drug: HS-20117; Drug: HS-20093
Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ AdebrelimabExperimentalNot described
Receives: Drug: HS-10370; Drug: Adebrelimab; Drug: HS-20093
Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ ChemotherapyExperimentalNot described
Receives: Drug: HS-10370; Drug: Adebrelimab; Drug: HS-20093; Drug: platinum (cisplatin or carboplatin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (9)

  1. 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

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

  2. Disease Control Rate (DCR)

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

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

  3. Time to Response (TTR)

    TTR by the Investigator According to RECIST v1.1

    Measured: 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).

  4. Duration of Response (DOR)

    DOR by the Investigator According to RECIST v1.1

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

  5. Progression-Free Survival (PFS)

    PFS by the Investigator According to RECIST v1.1

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

  6. Overall survival (OS)

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

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

  7. Plasma Concentrations of HS-10370

    Defined as the time from C1D1 to death from any cause

    Measured: 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)

  8. Maximum plasma concentration (Cmax)

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

    Measured: 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)

  9. Time of maximum concentration (Tmax)

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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start30 May 2025 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
762 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06963502
Sponsor's protocol ID
HS-10370-103
Status last verified
Apr 2025
First submitted
16 Apr 2025
Last updated
9 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10370, HS-20117 and Adebrelimab in people with Advanced Solid Tumors and Colorectal Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06963502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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