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Non-Small Cell Lung CancerPhase 1NCT06594874

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 1 study testing HS-10370, Adebrelimab and Cisplatin in people with Non-Small Cell Lung Cancer and Advanced Solid Tumors, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site 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 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) . Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HS-10370, Adebrelimab and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteChina
Study dates
31 Oct 2024to 1 Jan 2027
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.
  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

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

Xiaorong Dong, PhD contact

13986252286

xhzzdxr@126.com

China1 site

  • Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology

    Wuhan, Hubei

Other trials in China

About this study

Official title: 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

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) .

Being tested
HS-10370, Adebrelimab, Cisplatin, Carboplatin, Pemetrexed
Keywords
KRAS G12C, Non-Small Cell Lung Cancer, Metastatic Solid Tumor, Adebrelimab, Carboplatin, Pemetrexed, Cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

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

  • HS-10370Drug

    HS-10370 administered orally every day

  • AdebrelimabDrug

    Administered intravenously every 21 days; dose by label.

  • CisplatinDrug

    Administered intravenously every 21 days; dose by label.

  • CarboplatinDrug

    Administered intravenously every 21 days; dose by label.

  • PemetrexedDrug

    Administered intravenously every 21 days; dose by label.

Study groups in NCT06594874
Study groupRoleWhat they receive
Arm A: HS-10370 dose 1 + AdebrelimabExperimentalParticipants 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.
Receives: Drug: HS-10370; Drug: Adebrelimab
Arm B: HS-10370 dose 2 + AdebrelimabExperimentalParticipants 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.
Receives: Drug: HS-10370; Drug: Adebrelimab
Arm C: HS-10370+ Adebrelimab + Pemetrexed and PlatinumExperimentalParticipants 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
Receives: Drug: HS-10370; Drug: Adebrelimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed
Arm D: HS-10370+ Adebrelimab + PemetrexedExperimentalParticipants 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.
Receives: Drug: HS-10370; Drug: Adebrelimab; Drug: Pemetrexed
Arm E: HS-10370+ Pemetrexed and PlatinumExperimentalParticipants 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.
Receives: Drug: HS-10370; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

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 to first documented progression of disease or death from any cause, approximately 2 years.

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, approximately 2 years.

  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 C1D1 to disease progression or death, approximately 2 years.

  3. Time to Response (TTR)

    TTR by the Investigator According to RECIST v1.1

    Measured: Time from C1D1 until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, approximately 2 years.

  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

    Measured: C1D1 to date of death from any cause, approximately 5 years.

  7. Plasma Concentrations of HS-10370

    Defined as the time from C1D1 to death from any cause

    Measured: C1D1 to date of death from any cause. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation, approximately 2 years.

  8. Maximum plasma concentration (Cmax)

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

    Measured: C1D1 to date of death from any cause, approximately 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation.

  9. Time of maximum concentration (Tmax)

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

    Measured: C1D1 to date of death from any cause, approximately 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation

Timeline

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

  1. First posted19 Sep 2024
  2. Study start31 Oct 2024 (estimated)
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion1 Jan 2027 (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
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06594874
Sponsor's protocol ID
HS-10370-102
Status last verified
Sep 2024
First submitted
4 Sep 2024
Last updated
19 Sep 2024
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, Adebrelimab and Cisplatin in people with Non-Small Cell Lung Cancer and Advanced Solid Tumors, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site 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 12 inclusion and 26 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Xiaorong Dong, PhD (13986252286, xhzzdxr@126.com), or a site near the patient. 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 to first documented progression of disease or death from any cause, approximately 2 years.). 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 NCT06594874.

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 19 Sep 2024.

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