HRS-4642: HRS-4642 will be administrated per dose level in which the patients are assigned.
Study summary
The study is being conducted to evaluate the safety and tolerability of HRS-4642 in patients with advanced solid tumors harboring KRAS G12D mutation.To estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose \[RP2D\]) within investigated subject population groups
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. Male or female ≥ 18 years old.
3. Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D mutation
4. ECOG performance status of 0-1.
5. With a life expectancy of ≥3 months.
6. Have at least one measurable lesion.
7. Adequate laboratory parameters during the screening period
Exclusion Criteria:
1. Previously received KRAS G12D inhibitors
2. Priot radiotherapy within 28 days for non-thoracic radiation
3. Prior anti-tumor chemotherapy (\< 6 weeks if chemotherapy including nitrosoureas or mitomycin) within 4 weeks before the study drug administration
4. Any unresolved AEs \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or inclusion/exclusion criteria level (The investigators determined that safe and controllable toxicity was excluded, such as alopecia and ≤ grade 2 peripheral neuropathy ).
5. Central nervous system (CNS) metastases
6. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
7. Known history of hypersensitivity to any components of HRS-4642.
8. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Primary outcome measure(s)
Safety endpoints: adverse events(AEs), serious adverse events（SAEs）. — 24 months Assess safety and tolerability of HRS-4642 by way of adverse events (CTCAE v5.0).
Dose Limited Toxicity(DLT) — from day 1 to Day 21 A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness
Maximum tolerated dose (MTD) — From Day 1 to Day 21 Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of HRS-4642 treatment.
RP2D — 24 months RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.
Trial sites (1)
Facility
City
Region
Status
Shanghai Pulmonary Hospital
Shanghai
Shanghai Municipality
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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