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Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma (FIRST-308)

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ClinicalTrials.gov Identifier: NCT05948475
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
TransThera Sciences (Nanjing), Inc.

Study Description
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Brief Summary:
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: Tinengotinib 8 mg Drug: Tinengotinib 10 mg Drug: Physician's Choice Phase 3

Detailed Description:
Approximately 200 subjects will be enrolled. Eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice in Part A; and eligible subjects will be randomized in a 2:1 ratio to receive the recommended Part B dose or selected dose or Physician's Choice in Part B.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib VS Physician's Choice in Subjects With FGFR-altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma
Actual Study Start Date : December 20, 2023
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tinengotinib 8 mg QD
Tinengotinib will be administered in 28-day cycles.
 Drug: Tinengotinib 8 mg
Subjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles.
Experimental: Tinengotinib 10 mg QD
Tinengotinib will be administered in 28-day cycles.
 Drug: Tinengotinib 10 mg
Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.
Active Comparator: Physician's Choice
Physician's Choice treatments include FOLFOX or FOLFIRI
 Drug: Physician's Choice
For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Incidence, duration, and severity of adverse events (AEs) [ Time Frame: Up to 30 days from study discontinuation ]
    As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).

  2. Part B: PFS by BICR [ Time Frame: From first study drug administration until the date of first documented progression assessed by BICR or date of death from any cause, whichever came first, assessed up to 24 months ]
    Progression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.


Secondary Outcome Measures :
  1. Part A: ORR by Investigator [ Time Frame: Through study completion, an average of 9 months. ]
    ORR:objective response rate (ORR), the proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.

  2. Part A: DOR by Investigator [ Time Frame: Through study completion, an average of 9 months. ]
    Duration of response for CR or PR based on RECIST version 1.1.

  3. Part B:Overall Survival (OS) [ Time Frame: From first study drug administration until the date of death from any cause, assessed up to 24 months. ]
    OS is defined as the time from date of randomization to date of death of any cause.

  4. Part B: Objective Response Rate (ORR) by BICR and by Investigator: [ Time Frame: Through study completion, an average of 9 months. ]
    The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.

  5. Part B: Duration of Response (DOR) by BICR and by Investigator [ Time Frame: Through study completion, an average of 9 months. ]
    Duration of response for CR or PR based on RECIST version 1.1.

  6. Part B: PFS by Investigators per RECIST v1.1. [ Time Frame: From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. ]
    PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 18 years of age at the time of signing the informed consent form (ICF).
  2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.
  3. Documentation of FGFR2 fusion/rearrangement gene status
  4. Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.

Exclusion Criteria:

  1. Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs.
  2. Subjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment.
  3. Subjects with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, including those that have previously undergone potentially curative therapy.
  4. Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy.
  5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval.
  6. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy.
  7. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05948475


Contacts
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Contact: Jean Fan, MD 86-25-86901107 fan_jean@transtherabio.com
Contact: Hui Wang 86-25-86901159 wang_hui@transtherabio.com

Locations
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Sponsors and Collaborators
TransThera Sciences (Nanjing), Inc.
Investigators
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Principal Investigator: Milind Javle, MD M.D. Anderson Cancer Center
More Information
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Responsible Party: TransThera Sciences (Nanjing), Inc.
ClinicalTrials.gov Identifier: NCT05948475    
Other Study ID Numbers: TT420C2308
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TransThera Sciences (Nanjing), Inc.:
Refractory/Relapsed Cholangiocarcinoma
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms