Advanced Solid TumorsPhase 1/2NCT06520488
A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors
A Phase 1/2 study testing HRS-4642 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and preliminary efficacy of HRS-4642 in combination with antineoplastic agents in subjects with advanced solid tumors with KRAS G12D mutations, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HRS-4642
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2024to Jul 2027
- Phase
- Phase 1/2
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Age 18-75 years old (inclusive) at the time of signing the informed consent form
- Male or female
- ECOG score of 0 or 1
- Expected survival ≥ 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
Who cannot join
- Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study
- Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures
- Known hypersensitivity to any component of HRS-4642; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination
- Received other major surgery other than diagnosis or biopsy within 28 days before the first dose; Minor traumatic surgery (biopsy, laparoscopy, and drainage) within 7 days prior to the first dose; Presence of non-healing wounds (severe, non-healing, or dehiscence), untreated fractures
- Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or who have 5 half-lives of this investigational drug, whichever is shorter
- Use of a live attenuated vaccine within 28 days prior to the first dose of study medication, or anticipated need for a live attenuated vaccine during study treatment
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- Have a history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
- Those who have active pulmonary tuberculosis infection within 1 year before enrollment, or those who have a history of active pulmonary tuberculosis infection more than 1 year ago but have not been formally treated
- Active hepatitis B
- Presence of clinically significant acute or chronic pancreatitis
- Poorly controlled or severe cardiovascular and cerebrovascular diseases, arterior/venous thrombotic events within 6 months prior to study entry
- Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the start of study treatment, but screening can be performed if surgical treatment has been performed and the obstruction has been completely resolved
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Liwei Wang
About this study
Official title: Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of HRS-4642 in Combination With Anti-tumor Agents in Subjects With Advanced Solid Tumors
To evaluate the safety and preliminary efficacy of HRS-4642 in combination with antineoplastic agents in subjects with advanced solid tumors with KRAS G12D mutations, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
- Conditions
- Advanced Solid Tumors
- Being tested
- HRS-4642
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4642Drug
Treatment group Part I: HRS-4642 combined with SHR-A1921 Treatment group Part II: HRS-4642 combined with SHR-A1904 Treatment group Part II: HRS-4642 combined with AG
| Study group | Role | What they receive |
|---|---|---|
| Treatment group Part I/Part II/Part III | Experimental | Treatment group Part I: HRS-4642 combined with SHR-A1921 Treatment group Part II: HRS-4642 combined with SHR-A1904Treatment group Part II: HRS-4642 combined with AG Receives: Drug: HRS-4642 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: (IB Period):DLTs
Measured: Within 28 days of the first dose
Stage 1: (IB Period): adverse events (AEs)
Measured: Within 28 days of the first dos,About 1 year
Phase II: (Phase II):investigator-assessed ORR
Measured: Assessed every 6 weeks,About 1 year
Secondary outcomes (7)
Stage 1: (IB Period):Investigator-assessed objective response rate (ORR)
Measured: Assessed every 6 weeks,About 1 year
Phase II: (Phase II):DCR
Measured: Assessed every 6 weeks,About 1 year
Phase II: (Phase II):DoR
Measured: Assessed every 6 weeks,About 1 year
Phase II: (Phase II):OS
Measured: Assessed every 6 weeks+ About 1 year
Phase II: (Phase II):PFS
Measured: Assessed every 6 weeks,About 1 year
Phase II: (Phase II):OS
Measured: Assessed approximately once every 1 month,About 1 year
Phase II: (Phase II):Incidence and severity of AEs
Measured: Assessed approximately once every 1 month,About 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start9 Aug 2024
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520488
- Sponsor's protocol ID
- HRS-4642-202
- Status last verified
- Sep 2025
- First submitted
- 22 Jul 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cui J, Jiang K, Li W, Ni S, Zong H, Du J, He Y, Liu Z, Kong G, Zhang Y, Li X, Han H, Yao F, Chen Y, Zhou M, Wang L. KRAS-G12D inhibitor HRS-4642 plus chemotherapy in advanced KRASG12D-mutant pancreatic cancer: a phase 1b/2 trial. Nat Med. 2026 Jul 9. doi: 10.1038/s41591-026-04538-9. Online ahead of print.
PubMed 42426224