Status:
COMPLETED
A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b
Lead Sponsor:
Nuvation Bio Inc.
Collaborating Sponsors:
AnHeart Therapeutics Inc.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-...
Detailed Description
The Dose Escalation part (Part 1) of this study will evaluate safety and tolerability, and determine the tentative RP2D. Plasma exposure of DS-6051a and the exposure - QT interval prolongation relatio...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of advanced solid tumors that have relapsed from or are refractory to standard treatment or for which no standard treatment is available
- Part 1 Dose Escalation subjects must meet 1 of the following criteria:
- Solid tumors with documented ROS1, NTRK1, NTRK2, or NTRK3 rearrangement
- Neuroendocrine tumors
- Solid tumors with tumor-induced pain
- Part 2 Dose Expansion subjects must meet 1 of the following criteria:
- NSCLC with documented ROS1, NTRK1, NTRK2, or NTRK3 rearrangement
- k-RAS wild-type CRC with documented NTRK1, NTRK2, or NTRK3 rearrangement
- Other solid tumors with documented ROS1, NTRK1, NTRK2, or NTRK3 rearrangement
- Pulmonary LCNEC;
- Male or female ≥18 years of age
- Eastern Cooperative Oncology Group performance status 0 to 1
- Adequate organ function
- Adequate blood clotting function
- Women of childbearing potential must have a negative pregnancy test
- Willingness to provide archival tumor samples
- Other inclusion criteria may apply
Exclusion
- Hematological malignancies
- Known positive HIV infection, or active hepatitis B or C infection
- Comorbidity that would interfere with therapy
- Receipt of an allogeneic bone marrow or allogeneic stem cell transplant
- Concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor
- History of myocardial infarction and unstable angina within 6 months before study drug treatment; symptomatic congestive heart failure (Congestive Heart Failure New York Heart Association Class III or IV); congenital long QT syndrome; or ventricular arrhythmias defined as grade ≥2 according to NCI CTCAE, v4
- Clinically active primary central nervous system tumors or brain metastases with the exception of subjects with glioblastoma multiform that carry ROS1 rearrangement
- Unresolved toxicities from previous anticancer therapy
- Systemic treatment with anticancer therapy within 3 weeks before study drug treatment
- Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment
- Participation in a therapeutic clinical study within 3 weeks for biological treatments, and within 2 weeks or 5 half-lives, whichever is longer, for small molecule agents, before study drug treatment
- Concomitant treatment with strong inhibitors or inducers of CYP3A4 and P-glycoprotein
- Clinically significant malabsorption syndrome or other gastrointestinal disease that would impact drug absorption
- QTcF values higher than 450 ms at screening
- Breastfeeding
- Other exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02279433
Start Date
September 1 2014
End Date
March 1 2019
Last Update
June 24 2025
Active Locations (6)
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1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
Chao Family Comprehensive Cancer Center of
Orange, California, United States, 92868
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Dana Farber Cancer Inst.
Boston, Massachusetts, United States, 02215