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An Open-Label, Multicenter, Phase IB/II Clinical Study of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors

ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

This is a Phase IB/II clinical trial designed to evaluate HRS-7172 in combination with antitumor drugs in participants with advanced pancreatic cancer harboring RAS mutations or amplifications.

The study process includes a screening period (from signed informed consent to first dose), a treatment period (from first dose to last dose), and a follow-up period (safety and survival follow-up after last dose). A Safety Monitoring Committee (SMC), composed of the principal investigator and sponsor representatives, will be established during the study to review the safety and efficacy data generated. The SMC will make decisions on study-related matters, including but not limited to combination regimen dose exploration, combination regimen selection, efficacy expansion cohort selection, expansion initiation timing, and recommended dose for expansion (RDE).

This study aims to evaluate the safety, tolerability, and efficacy of HRS-7172 in combination with other antitumor therapies in participants with advanced or metastatic pancreatic cancer harboring RAS mutations or amplifications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of giving informed consent, have signed and dated the IRB/EC-approved informed consent form, and are willing and able to comply with scheduled visits, examination requirements, and other study procedures.

Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of sex.

ECOG performance status of 0 or 1.

Locally advanced or metastatic pancreatic cancer confirmed by histology and cytology, with RAS mutation/amplification detected by tissue or blood genetic testing.

Disqualifiers

Participants with untreated or active central nervous system (CNS) metastases or leptomeningeal metastases (including history thereof).

Concurrent other malignancies ≤ 3 years prior to the first dose, with the following exceptions: adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin carcinoma, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid carcinoma after radical surgery (hormonal therapy for non-metastatic prostate cancer or breast cancer is permitted).

Participants with uncontrollable tumor-related pain as determined by the investigator. Participants requiring analgesic therapy must have a stable analgesic regimen at study entry; symptomatic lesions eligible for palliative radiotherapy should have completed treatment before study entry.

Severe cardiovascular or cerebrovascular diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-7172 + AG + SHR-1316

    Drug

    HRS-7172 + AG + SHR-1316; low dose

  • HRS-7172 + AG + SHR-1316;

    Drug

    HRS-7172 + AG + SHR-1316; high dose

  • HRS-7172 + AG;

    Drug

    HRS-7172 + AG; low/high dose

  • HRS-7172 + AG + SHR-1316;

    Drug

    HRS-7172 + AG + SHR-1316; low/high dose

  • HRS-717 + HRS-4642+SHR-1316;

    Drug

    HRS-717 + HRS-4642+SHR-1316; low dose

  • HRS-717 + HRS-4642+SHR-1316;

    Drug

    HRS-717 + HRS-4642+SHR-1316; high dose

  • HRS-717 + HRS-4642;

    Drug

    HRS-717 + HRS-4642; low/high dose

  • HRS-717 + HRS-4642+SHR-1316;

    Drug

    HRS-717 + HRS-4642+SHR-1316; low/high dose

Treatment groups

140 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Treatment group A-low dose: HRS-7172 + AG + SHR-1316Experimental treatment 1 intervention
Group B: Treatment group A-high dose: HRS-7172 + AG + SHR-1316Experimental treatment 1 intervention
Group C: Treatment group A1: HRS-7172 + AGExperimental treatment 1 intervention
Group D: Treatment group A2: HRS-7172 + AG + SHR-1316Experimental treatment 1 intervention
Group E: Treatment group B-low dose: HRS-717 + HRS-4642+SHR-1316Experimental treatment 1 intervention
Group F: Treatment group B-high dose: HRS-717 + HRS-4642+SHR-1316Experimental treatment 1 intervention
Group G: Treatment group B1: HRS-717 + HRS-4642Experimental treatment 1 intervention
Group H: Treatment group B2: HRS-717 + HRS-4642+SHR-1316Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RDE in advanced pancreatic cancer with RAS mutation or amplification

Time frame
From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
2

Incidence and severity of adverse events (AEs) (per NCI-CTCAE V6.0 criteria)

Time frame
From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
3

ORR assessed by the investigator

Time frame
From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years

Secondary outcomes

1

Objective Response Rate (ORR) as assessed by the investigator

Time frame
From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
2

Disease Control Rate (DCR) as assessed by the investigator

Time frame
From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
3

Duration of Response (DoR) as assessed by the investigator

Time frame
From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
4

Progression-Free Survival (PFS) as assessed by the investigator

Time frame
From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: