TAC-001 for Solid Cancers

(INCLINE-101 Trial)

Recruiting at 15 trial locations

Overseen By Colleen Oliver

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Tallac Therapeutics

Disqualifiers: Other malignancies, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the treatment TAC-001 unique for solid cancers?

TAC-001 is unique because it likely involves targeting tumor-associated antigens (TAAs) to activate the immune system against cancer cells, which is different from traditional treatments that may not specifically target these antigens. This approach can potentially enhance the body's immune response to fight solid tumors more effectively. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

My organs are functioning well.

My cancer was confirmed by tissue examination.

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

Exclusion Criteria

I have brain metastases or cranial epidural disease.

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

I have no other cancers besides the one being treated in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive TAC-001 in a dose-escalation format to determine the recommended phase 2 dose (RP2D)

2 years

Dose Expansion

Participants receive TAC-001 to evaluate clinical benefit rate, overall response rate, and duration of response

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TAC-001

Trial Overview 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.

Participant Groups

Group I: TAC-001 Single-Agent Dose-Escalation Cohorts Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Tallac Therapeutics

Lead Sponsor

Trials

1

Recruited

70+

Findings from Research

In a first-in-human trial involving 15 patients with relapsed or refractory solid tumors, tumor-associated antigen cytotoxic T cells (TAA-Ts) were administered safely without any dose-limiting toxicities, demonstrating a promising new therapeutic approach.

Of the evaluable patients, 73% showed stable disease or better at day 45 post-infusion, with 6 patients remaining progression-free for a median of 13.9 months, indicating that TAA-Ts can effectively stabilize disease and prolong time to progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of Relapsed and Refractory Solid Tumors With Ex Vivo Expanded Multi-Tumor Associated Antigen Specific Cytotoxic T Lymphocytes: A Phase I Study. Hont, AB., Cruz, CR., Ulrey, R., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Increased circulating activated T-cells in lung cancer. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

MAGE-A10 is a nuclear protein frequently expressed in high percentages of tumor cells in lung, skin and urothelial malignancies. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

In vitro enrichment of tumor-initiating cells from human established cell lines. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy of Relapsed and Refractory Solid Tumors With Ex Vivo Expanded Multi-Tumor Associated Antigen Specific Cytotoxic T Lymphocytes: A Phase I Study. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Tumor-associated antigen-based personalized dendritic cell vaccine in solid tumor patients. [2021]