In short
INCB161734 hydrochloride dihydrate is an investigational oral substance being studied in pancreatic ductal adenocarcinoma with a KRAS G12D mutation. One authorised Phase 3 trial (DAWN-303) is testing whether adding INCB161734 to standard chemotherapy improves outcomes in 588 previously untreated participants with metastatic disease.
INCB161734 hydrochloride dihydrate is an investigational substance currently being evaluated in a Phase 3 clinical trial for people with previously untreated, KRAS G12D-mutated metastatic pancreatic ductal adenocarcinoma (PDAC). The trial, known as DAWN-303, is authorised but not yet recruiting participants.
Key points
- Phase 3 randomised, double-blind trial in previously untreated metastatic pancreatic cancer
- Targets the KRAS G12D mutation, found in a subset of pancreatic ductal adenocarcinoma
- Trial enrols 588 participants across two treatment arms
- Compares INCB161734 plus chemotherapy against placebo plus chemotherapy
- Main measures include overall survival, progression-free survival, and objective response
- Trial status is authorised, meaning recruitment has not yet started
What is INCB161734 hydrochloride dihydrate?
INCB161734 hydrochloride dihydrate is an investigational oral substance being developed for the treatment of pancreatic ductal adenocarcinoma carrying a KRAS G12D mutation. No marketing authorisation is recorded in the trial data; the substance remains under clinical investigation. In the DAWN-303 trial, INCB161734 is administered as a 1200 mg oral dose alongside standard chemotherapy.
How does INCB161734 hydrochloride dihydrate work?
The trial record does not state the molecular mechanism of INCB161734. The study investigates whether adding INCB161734 to chemotherapy improves outcomes specifically in participants whose tumours carry a KRAS G12D mutation, a genetic alteration that drives cancer growth in a subset of pancreatic cancers.
Which conditions is it studied for?
- Pancreatic ductal adenocarcinoma (PDAC) — the most common form of pancreatic cancer, arising from the cells lining the pancreatic ducts. INCB161734 is being studied in the metastatic form of this disease, where the cancer has spread beyond the pancreas, and specifically in tumours that carry the KRAS G12D mutation.
How is INCB161734 hydrochloride dihydrate given?
INCB161734 hydrochloride dihydrate is given orally at a dose of 1200 mg in the DAWN-303 trial. The chemotherapy backbone in the study is given intravenously and includes nab-paclitaxel (Abraxane), fluorouracil, irinotecan, oxaliplatin, calcium folinate hydrate, and gemcitabine.
What do the clinical trials show?
The DAWN-303 trial is a randomised, double-blind Phase 3 study comparing INCB161734 plus chemotherapy with placebo plus chemotherapy in 588 participants with previously untreated, KRAS G12D-mutated metastatic pancreatic ductal adenocarcinoma. The trial is currently authorised, meaning it has received regulatory approval to proceed but has not yet started enrolling participants.
The primary measures are overall survival (OS), defined as the time from randomisation to death from any cause; progression-free survival (PFS) by blinded independent central review (BICR), defined as the time from randomisation to first documented progression or death; and objective response by BICR, defined as a best overall response of complete response or partial response per RECIST v1.1.
Participants must have metastatic pancreatic ductal adenocarcinoma with a KRAS G12D mutation and no prior systemic therapy for their disease.
What side effects are known?
The trial record does not list side effects for INCB161734 hydrochloride dihydrate. As the study is authorised but not yet recruiting, safety data from this trial are not yet available.