Jiangsu HengRui starts Phase 3 KRAS G12D pancreatic cancer trial, only one of its kind
HRS-4642 becomes the sole Phase 3 asset in KRAS G12D pancreatic cancer as Jiangsu HengRui moves the 588-patient trial into recruiting, testing whether the target's promise translates to survival benefit.
Executive Summary
- Jiangsu HengRui Medicine's Phase 3 trial of HRS-4642 in first-line pancreatic cancer moved into active recruitment, a routine but necessary step toward a multi-year registrational program.
- The trial stands alone as the only Phase 3 test of the KRAS G12D target in pancreatic cancer, even as a cluster of earlier-phase rivals pursue the same mutation across tumor types.
- Pancreatic cancer has no validated targeted mechanism in first-line treatment, so a survival benefit added to standard chemotherapy would be the result that distinguishes this approach from the chemotherapy backbone it is tested against.
- The enrollment target held flat, the protocol shows no amendment churn, and completion is still years out, all pointing to a program in its early operational phase rather than one showing distress.
The status change
The trial, registered as NCT07232875, moved from Not yet recruiting to Recruiting status on July 15, 2026, according to its ClinicalTrials.gov record. The study pairs HRS-4642 injection with AG chemotherapy (gemcitabine and nab-paclitaxel) against placebo plus AG in patients with KRAS G12D-mutated advanced or metastatic pancreatic cancer, enrolling in China with a target of 588 patients. The trial started November 21, 2025 and carries a primary completion date of April 1, 2029. NCT07232875+1HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic CancerNCT07232875HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic CancerJul 15, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial will test
The study registers two primary endpoints, overall survival and progression-free survival assessed by blinded independent central review under RECIST 1.1, measured against the AG chemotherapy backbone plus placebo. Secondary endpoints include objective response rate, disease control rate, duration of response, and adverse-event incidence, each assessed by both central review and investigator. The randomized, active-comparator design against a chemotherapy regimen already in first-line use means the trial is built to test whether adding a KRAS G12D-directed agent produces a survival benefit beyond chemotherapy alone, in a first-line population selected specifically for the driver mutation. NCT07232875HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic CancerNCT07232875
Where it sits in the field
Thirteen industry trials have registered for the KRAS G12D target in pancreatic cancer across 11 sponsors, and this trial is the only one to reach Phase 3. The nearest direct comparators in Phase 3 development for this target-indication pairing are Genfleet Therapeutics' GFH375 and Astellas Pharma's ASP3082, both in pancreatic cancer, alongside Jiangxi Kvvit's DN022150 and Incyte's INCB161734. A broader cohort of KRAS G12D programs, including Bristol-Myers Squibb's BMS-986504, Revolution Medicines' RMC-6291, and Eli Lilly's LY3962673, remain in Phase 1 testing across tumor populations spanning multiple cancer types, reflecting a target still in early clinical development outside this one late-stage entrant. One prior KRAS G12D pancreatic cancer trial on record was terminated, the only resolved outcome in this target-indication pairing.
Operational signals
The enrollment target held at 588 patients with no change, a routine reading under the operational model's threshold for a shift large enough to flag. The protocol has logged no amendments to endpoints, eligibility, or the primary completion date since the trial was first submitted, and the registry-churn proxy for this study reads Stable. Jiangsu HengRui Medicine has completed 272 of 300 prior trials globally, a 91% completion rate, and has a separate Phase 1/2 study of HRS-4642 in combination with other antitumor therapies for tumors spanning multiple cancer types also recruiting. NCT07232875HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic CancerNCT07232875
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.