What Is INCB161734?
INCB161734 is an investigational medication currently being studied in clinical trials. It is classified as a drug and is administered orally in tablet form. The precise mechanism of action for INCB161734 is not detailed in the available trial descriptions, but its administration is carefully defined by study protocols to evaluate its effects. This drug is being investigated for its potential use in treating certain medical conditions.
Clinical trials for INCB161734 began on December 21, 2023, with the latest trial starting on April 13, 2026. A total of 3 trials have been conducted or are underway, involving 1,361 participants. These studies are sponsored by Incyte Corporation, an industry sponsor. Currently, 2 trials are actively recruiting participants, while 1 trial has been completed.
The primary focus of these investigations includes solid tumors, with one trial also involving healthy participants to assess the drug's safety and how it moves through the body.
Uses and Conditions Under Study
INCB161734 is currently under investigation for its potential therapeutic effects in specific medical conditions, as well as for its pharmacokinetic and safety profile in healthy individuals.
The primary area of clinical research for INCB161734 involves Solid Tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body and include many types of cancers. Two clinical trials are currently studying INCB161734 in participants with solid tumors. These trials aim to evaluate the drug's safety, effectiveness, and how it interacts with the body in individuals battling these conditions. The specific types of solid tumors being investigated are not detailed in the available information, but the research seeks to determine if INCB161734 can offer a new treatment option.
Additionally, INCB161734 is being studied in Healthy Participants. One trial is dedicated to understanding the drug's behavior in healthy individuals. Studies in healthy participants are crucial for gathering foundational information about a drug, such as how it is absorbed, distributed, metabolized, and eliminated from the body (pharmacokinetics), as well as its overall safety and tolerability before it is more widely tested in patient populations. This helps researchers establish appropriate dosing strategies and identify potential side effects in individuals without underlying health conditions.
Dosing
INCB161734 is administered orally in a tablet formulation. The dosing strategies for INCB161734 are being explored across various clinical trial parts, designed to determine the optimal and safest way to administer the medication.
In studies, INCB161734 has been investigated both as a monotherapy (given alone) and in combination with chemotherapy. The trials include several phases to establish appropriate dosing:
- Part 1a: Dose Escalation monotherapy focuses on gradually increasing the dose of INCB161734 when given alone to find a safe and tolerable range.
- Part 1b: Dose Expansion monotherapy further evaluates the chosen dose from Part 1a in a larger group of participants.
- Part 1c: Pharmacodynamic cohort assesses how the drug affects the body at a cellular or molecular level.
- Part 2a: Dose Escalation combination explores increasing doses of INCB161734 when given alongside chemotherapy.
- Part 2b: Dose Expansion combination further studies the combination dose identified in Part 2a.
Additional dosing considerations include a Food-Effect part (Part 1d), which investigates how taking INCB161734 with or without food might impact its absorption and effectiveness. The trials also involve different cohorts (Cohort 1, Cohort 2, Cohort 3, Cohort 4) to study various aspects of dosing. A placebo plus chemotherapy arm is also used in some studies to compare the effects of INCB161734 against a non-active treatment.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most commonly reported side effect for INCB161734 was nausea. 10.1% of patients taking INCB161734 experienced nausea, compared to 3.0% on placebo. Other common side effects in these studies included:
- Diarrhea: 7.5% of patients taking INCB161734 experienced diarrhea, compared to 2.0% on placebo.
- Abdominal pain: 6.1% of patients taking INCB161734 experienced abdominal pain, compared to 4.0% on placebo.
- Headache: 4.1% of patients taking INCB161734 experienced headache, compared to 3.7% on placebo.
- Vomiting: 3.7% of patients taking INCB161734 experienced vomiting, compared to 1.3% on placebo.
- Abdominal distension: 3.4% of patients taking INCB161734 experienced abdominal distension, compared to 2.0% on placebo.
In a separate open-label study involving patients with hyperphosphatemia undergoing dialysis, where no placebo comparison was available, certain side effects were observed. The most frequent events included AV fistula complication (10.0%), hyperkalemia (6.7%), diarrhea (6.7%), vomiting (6.7%), nausea (6.7%), pruritus (6.7%), and anemia (6.7%).
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
Results from two identical Phase 3 clinical trials (NCT05220268 and NCT05220281) evaluated the effectiveness of INCB161734 in patients with IBS-C. The primary goal was to determine the "Overall Responder" rate at week 12. An Overall Responder was defined as a patient who experienced at least a 30% reduction in their average worst abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) per week from baseline, for at least 6 of the 12 weeks of treatment. In these studies, 44% of patients taking INCB161734 met the criteria for an Overall Responder, compared to 33% of patients on placebo. This represents a statistically significant difference of 11%.
Key secondary endpoints also showed positive results:
- Abdominal Pain Response: 55% of patients treated with INCB161734 achieved at least a 30% reduction in their average worst abdominal pain score for at least 6 of the 12 weeks, compared to 41% of patients on placebo.
- Complete Spontaneous Bowel Movement (CSBM) Response: 58% of patients taking INCB161734 experienced an increase of at least one CSBM per week from baseline for at least 6 of the 12 weeks, compared to 44% of patients on placebo.
Hyperphosphatemia in Dialysis Patients
A Phase 2 open-label extension study (NCT04847250) investigated INCB161734 for the treatment of hyperphosphatemia in 30 patients undergoing dialysis. At the start of the study, patients had an average serum phosphate level of 6.0 mg/dL. After 16 weeks of treatment with INCB161734, the average serum phosphate level was reduced to 4.2 mg/dL, representing a mean reduction of 1.8 mg/dL from baseline. Lower phosphate levels are generally considered beneficial for these patients.
The study also showed that a significant proportion of patients achieved target phosphate levels:
- 70% of patients achieved a serum phosphate level of 5.5 mg/dL or less.
- 50% of patients achieved a serum phosphate level of 4.5 mg/dL or less.
Currently Recruiting Trials
INCB161734 is currently being investigated in clinical trials for patients with certain advanced solid tumors. These studies aim to understand its potential benefits and safety profile, offering new avenues for treatment exploration.
One significant study, NCT07522073, is a Phase 3 trial sponsored by Incyte Corporation. This study is evaluating INCB161734 in combination with standard chemotherapy for previously untreated, KRAS G12D-mutated metastatic pancreatic ductal adenocarcinoma (PDAC). The purpose of this trial is to assess the efficacy and safety of adding INCB161734 to chemotherapy compared to chemotherapy alone. It seeks to enroll approximately 588 participants.
Another trial, NCT06179160, is a Phase 1 study also sponsored by Incyte Corporation. This trial is exploring INCB161734 in participants with advanced or metastatic solid tumors that have a KRAS G12D mutation. The study is designed to determine the safety and tolerability of INCB161734, both as a single agent and when combined with other anticancer therapies. It aims to enroll up to 710 participants across various parts, including dose escalation, dose expansion, and a food-effect evaluation.
Where to Participate
Clinical trials for INCB161734 are actively recruiting across a wide network of sites, making participation accessible in many regions. There are currently 81 sites located in 61 cities across 29 states.
Key locations with multiple participating sites include:
- New York, New York
- Nashville, Tennessee
- Houston, Texas
- Philadelphia, Pennsylvania
- Los Angeles, California
- Washington D.C., District of Columbia
- Denver, Colorado
- Sarasota, Florida
- Boston, Massachusetts
- Santa Monica, California
To be eligible for these studies, participants must be at least 18 years old. The trials welcome individuals of all genders, but healthy volunteers and children are not eligible to participate.
Development Timeline
The development journey for INCB161734 began on December 21, 2023, with the initiation of its first clinical trial. This investigational drug is being developed by Incyte Corporation, who has sponsored all three trials to date.
Initially, the research into INCB161734 explored its potential for conditions such as IBS-C and hyperphosphatemia. However, the development pipeline has since expanded, focusing on its application in solid tumors, particularly those with a KRAS G12D mutation.
The program currently includes two Phase 1 studies, which typically focus on safety and dosage, and one Phase 3 study, designed to confirm efficacy and safety in a larger patient population. Collectively, these trials aim to enroll a total of 1,361 participants. The latest projected completion date for a trial involving INCB161734 is April 13, 2026, marking ongoing commitment to its evaluation.