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Solid TumorsPhase 1NCT02279433

A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b

A Phase 1 study testing DS6051b in people with Solid Tumors, run by Nuvation Bio Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
DS6051b
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
6 sitesUnited States
Study dates
Sep 2014to Mar 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Inst.

    Boston, Massachusetts, 02215

  • New York University

    New York, New York, 10016

  • Chao Family Comprehensive Cancer Center of

    Orange, California, 92868

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1/1B Multi-Center, Non Randomized, Open-Label, Multiple Dose First-In-Human Study Of DS-6051b, An Oral ROS1 And NTRK Inhibitor, In Subjects With Metastatic and/or Unresectable Solid Tumors

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-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). In addition, this study will also assess the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and preliminary efficacy of DS-6051b.

Read the 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 relationship will also be assessed. Approximately 30 subjects with advanced solid tumors harboring ROS1 or NTRK1, NTRK2, or NTRK3 rearrangement, neuroendocrine carcinoma, or with advanced solid tumors and tumor-induced pain will be enrolled.

The Food Effect (FE) part of this study is to determine the effect of food on the PK of DS-6051a following administration of a single oral dose of DS-6051b. The safety and tolerability of DS-6051b administered with or without food will also be assessed.

After the safety profile of DS-6051b is adequately evaluated, the Dose Expansion part (Part 2) will be initiated to further assess the safety and tolerability, and preliminarily evaluate the efficacy of DS-6051b at the tentative RP2D. Approximately 40 cancer subjects carrying a ROS1 or NTRK1, NTRK2, or NTRK3 rearrangement will be enrolled.

Conditions
Solid Tumors
Being tested
DS6051b
Keywords
Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Neuroendocrine Tumors, Pancreatic Neoplasms
Medical subject headings
Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Neuroendocrine Tumors, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS6051bDrug

    Also called Investigational product, DS-6051a (a free base of 6051b)

    DS-6051b 50 mg and 200 mg capsules for oral administration

Study groups in NCT02279433
Study groupRoleWhat they receive
DS-6051bExperimentalDS-6051b is orally administered as 50 mg and 200 mg capsules once daily on Days 1 to 21 of a 21-day cycle. Dose escalation in Part 1 will continue until tentative Recommended Part 2 Dose (RP2D) is determined. In Part 2 participants will receive the RP2D.
Receives: Drug: DS6051b

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of participants with dose-limiting toxicities

    Measured: within 21 days following the first dose of treatment

  2. Tumor response

    Tumor response will be assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

    Measured: up to 2 years

Secondary outcomes (4)

  1. Maximum concentration (Cmax) for DS-6051a

    Measured: At Days 1 and 15 of Cycle 1 (21 days)

  2. Time to maximum concentration (Tmax) for DS-6051a

    Measured: At Days 1 and 15 of Cycle 1 (21 days)

  3. Area under the concentration-time curve from time zero to t (AUC0-t) for DS-6051a

    Measured: At Days 1 and 15 of Cycle 1 (21 days)

  4. Change from baseline in QTc interval

    ECGs performed to assess QTc interval (ms) at baseline and on study treatment and at the end of treatment visit.

    Measured: within 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionMar 2019
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02279433
Sponsor's protocol ID
DS6051-A-U101
Status last verified
Jun 2025
First submitted
15 Oct 2014
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS6051b in people with Solid Tumors, run by Nuvation Bio Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of participants with dose-limiting toxicities (time frame: within 21 days following the first dose of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02279433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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