A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients

Solid Tumor Clinical Trial

Official title:

A Phase 2 Study of TL118 for the Treatment of Patients With Solid Tumors Harboring NTRK Gene Fusions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06010342
• Other study ID #: TL-TRK-202101
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Teligene US
• Contact: Xiaoyang Xia
• Phone: 8053009373
• Email: xiaoyang.xia[@]teligene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the study will be to evaluate the efficacy of TL118 in participants with solid tumors harboring NTRK gene fusions

Description:

TL118 is an orally active inhibitor of the tropomyosin receptor kinase (Trk) family consists of TrkA, TrkB, and TrkC. These receptors are encoded by the NTRK1, NTRK2 and NTRK3 genes, and oncogenic fusions of NTRK may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective TL118 is for the treatment of patients with solid tumors harboring NTRK gene fusions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years old and above, male or female

2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3 gene fusion that is predicted to translate into a fusion protein with a functional tropomyosin receptor kinase (TRK)A/B/C kinase domain, without a concomitant second onco-driver

3. Patients must have had disease progression during or after prior treatment for their tumor, or would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy or are not suitable - in the opinion of the Investigator - to receive standard of care therapy; prior treatment with approved or investigational TRK inhibitors in patients who have tumors that harbor NTRK1/2/3 gene rearrangements is not allowed, except for prior TRK treatment for less than 28 days due to intolerable toxicity)

4. At least one measurable lesion

5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2

6. A minimum life expectancy of > 3 months

7. Adequate bone marrow reserve, hepatic, renal, and coagulation function Other inclusion criteria apply for participating in the Study

Exclusion Criteria:

1. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion > 30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines (TCMs) indicated for the tumor (including Chinese patent medicine) within 2 weeks prior to enrollment

2. Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5 half-lives from the last dose of IP (whichever is shorter)

3. Any unresolved toxicities from prior therapy greater than Grade 1, at the time of screening with the exception of toxicities posing no safety risk in the opinion of the Investigator

4. Active central nervous system metastases

5. Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low-risk cancer

6. Any active infection which has not been controlled at screening Other exclusion criteria apply for participating in the Study

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• TL118 Capsule
Oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teligene US

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		Pre-dose up to approximately 24 months post-dose
Secondary	Duration of Response (DoR)		Pre-dose up to approximately 24 months post-dose
Secondary	Disease Control Rate (DCR)		Pre-dose up to approximately 24 months post-dose
Secondary	Progression Free Survival (PFS)		Pre-dose up to approximately 24 months post-dose
Secondary	Time to Tumor Progression (TTP)		Pre-dose up to approximately 24 months post-dose
Secondary	Time to Response (TTR)		Pre-dose up to approximately 24 months post-dose
Secondary	Time to Treatment Failure (TTF)		Pre-dose up to approximately 24 months post-dose
Secondary	Overall Survival (OS)		Pre-dose up to approximately 24 months post-dose
Secondary	1-year Progression Free Survival		Pre-dose up to approximately 24 months post-dose
Secondary	1-year Survival		Pre-dose up to approximately 24 months post-dose
Secondary	Number of Participants Experiencing Adverse Events (AE)		Pre-dose up to approximately 24 months post-dose
Secondary	Number of Participants Experiencing Adverse Drug Reactions (ADR)		Pre-dose up to approximately 24 months post-dose
Secondary	Number of Participants Experiencing Serious Adverse Events (SAE)		Pre-dose up to approximately 24 months post-dose
Secondary	Number of Participants Experiencing Serious Adverse Reactions (SAR)		Pre-dose up to approximately 24 months post-dose
Secondary	Area Under The Curve (AUC) of TL118		Pre-dose up to 12 hours post-dose
Secondary	Maximum Plasma Concentration (Cmax) of TL118		Pre-dose up to 12 hours post-dose
Secondary	Minimum Plasma Concentration (Cmin) of TL118		Pre-dose up to 12 hours post-dose
Secondary	Time to Peak Drug Concentration (Tmax) of TL118		Pre-dose up to 12 hours post-dose
Secondary	TL118 half-life (T1/2)		Pre-dose up to 12 hours post-dose
Secondary	Apparent Clearance (CL/f) of TL118		Pre-dose up to 12 hours post-dose
Secondary	Volume of Distribution (Vz/F) of TL118		Pre-dose up to 12 hours post-dose