INCLINE-101: A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors

• Sponsor: Tallac Therapeutics (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05399654
• Collaborator: (none)
• Enrollment: 200
• Arm: 1
• Anticipated Duration (Months): 46.5

Study Details

Study Description

Brief Summary

INCLINE-101 is an open label, multicenter Phase 1/2 study designed to evaluate safety, pharmacokinetics (PK), and preliminary anti-tumor activity of TAC-001 administered intravenously.

Condition or Disease	Intervention/Treatment	Phase
Advanced or Metastatic Solid Tumors	Drug: TAC-001	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
• Anticipated Study Start Date: Jul 5, 2022
• Anticipated Primary Completion Date: Jan 27, 2026
• Anticipated Study Completion Date: May 19, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAC-001 Single-Agent Dose-Escalation Cohorts	Drug: TAC-001; TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)

Outcome Measures

Primary Outcome Measures

1. Dose-Escalation Stage: RP2D for TAC-001 [2-years]

   To identify the recommended dose phase 2 dose (RP2D) for further evaluation of TAC-001 when administered as monotherapy in subjects with advanced or metastatic solid tumors

2. Dose Expansion: Characterization of ORR for TAC-001 [2 years]

   To evaluate preliminary efficacy of TAC-001 by estimating the overall response rate (ORR; combined complete response [CR] and partial response [PR]) as assessed by the Investigator per RECIST 1.1 and iRECIST

3. Dose Expansion: Characterization of duration of response for TAC-001 [2 years]

   To evaluate preliminary efficacy of TAC-001 by estimating the duration of response as assessed by the Investigator per RECIST 1.1 and iRECIST

4. Dose Expansion: Characterization of clinical benefit rate for TAC-001 [2 years]

   To evaluate preliminary efficacy of TAC-001 by estimating the clinical benefit rate as assessed by the Investigator per RECIST 1.1 and iRECIST

Secondary Outcome Measures

1. Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs) [2 years]

   To evaluate the safety of TAC-001 monotherapy through the evaluation of incidence and severity of nonserious AEs and SAEs, including immune-related adverse events (irAEs), as graded by investigators according to CTCAE version 5.0

2. Maximum Plasma Concentration (Cmax) [2 years]

   To evaluate the Cmax of TAC-001 monotherapy

3. Maximum Plasma Concentration (Tmax) [2 years]

   To evaluate the Tmax of TAC-001 monotherapy

4. Area Under the Plasma Concentration-Time Curve (AUC) [2 years]

   To evaluate the AUC of TAC-001 monotherapy

5. Terminal Half-Life [2 years]

   To evaluate the terminal half-life of TAC-001 monotherapy

6. Clearance of TAC-001 [2 years]

   To evaluate the drug clearance of TAC-001 monotherapy

7. Evaluation of immunogenicity of TAC-001 [2 years]

   Incidence of antidrug antibodies (ADA) against TAC-001

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Histologically or cytologically-documented solid tumors.

2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

3. Demonstrate adequate organ function.

Exclusion Criteria:

1. Prior history of or active malignant disease other than that being treated in this study.

2. Known brain metastases or cranial epidural disease.

3. A known hypersensitivity to the components of the study therapy or its' analogs.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tallac Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tallac Therapeutics
• ClinicalTrials.gov Identifier: NCT05399654
• Other Study ID Numbers: INCLINE-101
• First Posted: Jun 1, 2022
• Last Update Posted: Jun 3, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jun 3, 2022