Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer

Palo Alto (17 mi)

Overseen bySarina A. Piha-Paul, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: TransThera Sciences (Nanjing), Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a first-in-human, phase I clinical research study with TT-00420, an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor micro-environment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors. The study consists of a dose escalation part followed by a MTD expansion part.

Eligibility Criteria

This trial is for adults aged 18-75 with advanced solid tumors or triple negative breast cancer (TNBC) that have no standard treatment options left. Participants must have at least one measurable tumor and be in good physical condition (ECOG status of 0 or 1). They should also meet certain blood cell count criteria and liver function limits.

Inclusion Criteria

I am between 18 and 75 years old.

I have advanced cancer with no standard treatment options left.

My breast cancer is triple-negative and lacks estrogen and progesterone receptors.

My cancer did not respond or has returned after chemotherapy.

I am fully active or can carry out light work.

Treatment Details

The study tests TT-00420, a new oral drug aimed at inhibiting specific enzymes to fight TNBC and other solid tumors. It includes an initial phase to find the right dose followed by a second phase to confirm this dose's safety and effectiveness.

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

A Dose Expansion cohort will be opened to enroll patients with selected advanced solid tumors and evaluate the safety, PK and preliminary efficacy of TT-00420 to determine the recommended phase 2 dose in patients with advanced solid tumors.

Group II: Dose EscalationExperimental Treatment1 Intervention

Eligible adult patients with advanced solid tumors will be enrolled into Dose Escalation cohorts and treated with TT-00420 at different dose cohorts. Starting dose will be 1 mg p.o., q.d. An ABLRM guided by the EWOC principle will evaluate the risk of under-dose or over-dose for the dose tested in each cohort and provide the recommendation dose for next cohort. Dose Escalation Teleconference will be held after the last evaluable patient complete Cycle 1 treatment in each dose cohort to evaluate DLT, determine MTD and/or DRDE.