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TAC-001 for Solid Cancers (INCLINE-101 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Tallac Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically-documented solid tumors.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

INCLINE-101 Trial Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?

This trial is for patients with certain advanced or metastatic solid tumors. Participants must have a confirmed diagnosis, adequate organ function, and be able to perform daily activities with little to no assistance (ECOG performance status 0 or 1). People with brain metastases, allergies to study drugs or similar compounds, or another active cancer are not eligible.Check my eligibility

What is being tested?

The INCLINE-101 study is testing the safety and initial effectiveness of TAC-001 when given through an IV. It's an early-stage trial (Phase 1/2) that also looks at how the body processes the drug.See study design

What are the potential side effects?

Potential side effects of TAC-001 are not specified here but may include typical reactions related to cancer treatments such as fatigue, nausea, inflammation in organs due to immune response, and possible infusion-related reactions.

INCLINE-101 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer was confirmed by tissue examination.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

INCLINE-101 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Expansion: Characterization of ORR for TAC-001

Dose Expansion: Characterization of clinical benefit rate for TAC-001

Dose Expansion: Characterization of duration of response for TAC-001

+1 more

Secondary outcome measures

Area Under the Plasma Concentration-Time Curve (AUC)

Clearance of TAC-001

Evaluation of immunogenicity of TAC-001

+4 more

INCLINE-101 Trial Design

1Treatment groups

Experimental Treatment

Group I: TAC-001 Single-Agent Dose-Escalation CohortsExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tallac TherapeuticsLead Sponsor

Media Library

TAC-001 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05399654 — Phase 1 & 2

Solid Tumors Research Study Groups: TAC-001 Single-Agent Dose-Escalation Cohorts

Solid Tumors Clinical Trial 2023: TAC-001 Highlights & Side Effects. Trial Name: NCT05399654 — Phase 1 & 2

TAC-001 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05399654 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the specific goals of this research project?

"The main metric that will be used to judge the success of this trial, which takes place over 2 years, is the Dose-Escalation Stage: RP2D for TAC-001. Additionally, researchers will also be looking at Terminal Half-Life, Area Under the Plasma Concentration-Time Curve (AUC), and Maximum Plasma Concentration (Tmax) as potential indicators of success."

Answered by AI

Are patients being signed up for this trial right now?

"Yes, this is accurate. The clinical trial in question is recruiting patients at the moment. It was first posted on June 28th, 2022 and most recently updated on October 11th of the same year."

Answered by AI

How many people are allowed to be in this trial at one time?

"That is accurate. According to the clinicaltrials.gov website, this clinical trial has an open call for participants. The first posting was on 6/28/2022 and there have been subsequent updates, with the latest being on 10/11/2022. They are looking to enroll 200 individuals from 3 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05399654.