Study of TUB-040 in Patients With Recurrent or Progressive Uterine Cancer After Chemotherapy and Immune Therapy

Conditions

• Uterine Endometrial Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TUB-040 - Dose escalation — DRUG
  TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle.
• TUB-040 - RP2D — DRUG
  TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle. Dose based on the RP2D

Study Details

The goal of this clinical study is to learn more about the study drug TUB-040, safety, tolerability, pharmacokinetics (PK), and effectiveness in treating patients with recurrent or progressive uterine endometrial cancer after platinum-based chemotherapy and immune checkpoint inhibitor therapy. The primary objectives of Phase 1 of this study are to determine the safety and tolerability of TUB-040 and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). The primary objective of Phase 2 of this study is to evaluate the efficacy of TUB-040 monotherapy at the RP2D in endometrial cancer.

Key Dates

First listed

Aug 4, 2026

Start date

Oct 31, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1: Dose Escalation of TUB-040
  Participants will receive escalating doses of TUB-040 to determine recommended Phase 2 dose (RP2D).
• Experimental: Phase 2: Monotherapy of TUB-040
  Participants in Phase 2 will receive the recommended dose of TUB-040 monotherapy determined in Phase

Primary Outcome Measure

Phase 1: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 3 years ]

Central Contacts

• Tubulis Clinical Trial Inquiries
  +49 175 800 5594
  [email protected]

Locations (4)

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