A Trial of TTI-621 in Combination With Doxorubicin in Patients With Leiomyosarcoma

  • STATUS
    Recruiting
  • End date
    Jan 4, 2024
  • participants needed
    80
  • sponsor
    Pfizer
Send
Updated on 4 October 2022
See if I qualify
measurable disease
doxorubicin
gemcitabine
docetaxel
cancer chemotherapy
angiosarcoma
soft tissue sarcoma
liposarcoma
undifferentiated pleomorphic sarcoma
leiomyosarcoma
epithelioid sarcoma

Summary

Multi-center, open-label, Phase I/II dose escalation and expansion trial of TTI-621 in patients with unresectable or metastatic high-grade leiomyosarcoma.

Description

This trial will be conducted in 2 phases: Phase I (Dose Escalation of TTI-621 in combination with doxorubicin) and Phase II (Dose Expansion of TTI-621 in combination with doxorubicin).

Phase I (Dose Escalation of TTI-621 in combination with doxorubicin) will enroll patients with soft-tissue sarcomas including leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma or epithelioid sarcoma

Phase II (Dose Expansion of TTI-621 in combination with doxorubicin) will include 2 cohorts: Cohort A and Cohort B. The lower selected dose of TTI-621 will be studied in Cohort A while the higher dose of TTI-621 will be studied in Cohort B. Patients with leiomyosarcoma will be enrolled.

Details
Condition Leiomyosarcoma
Treatment doxorubicin, TTI-621
Clinical Study IdentifierNCT04996004
SponsorPfizer
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Histologically-confirmed high-grade soft tissue sarcoma that is metastatic or locally advanced and not amenable to curative treatment with surgery or radiation
In the Dose Escalation phase, indications will be limited to high-grade leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma and epithelioid sarcoma
In the Dose Expansion phase, indications will be limited to high-grade leiomyosarcoma
Objective evidence of disease progression unless disease is newly-diagnosed
Measurable disease per RECIST v1.1 (expansion cohorts)
Adequate organ and hematologic function
No more than 1 prior treatment regimen for advanced disease, which is limited to gemcitabine with docetaxel
Anthracycline-naïve
Patients who were treated with a prior chemotherapy regimen must have completed treatment at least three weeks before initiation of study treatment
All adverse events from prior treatment must be NCI CTCAE v5 Grade ≤ 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline
Radiotherapy, including palliative radiotherapy, completed at least two weeks prior to treatment; palliative radiation to non-target lesions while on study is allowed

Exclusion Criteria

History of acute coronary syndromes
History of or current Class II, III, or IV heart failure
History or evidence of known CNS metastases or carcinomatous meningitis
Significant bleeding disorders, vasculitis or a significant bleeding episode from the GI tract
History of severe hypersensitivity reactions to antibodies
Systemic steroid therapy
History or autoimmune disease that has required systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs
Prior organ transplantation including allogenic or autologous stem cell transplantation
Prior treatment with anti-CD47 or anti-SIRPα therapy
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

measurable disease
doxorubicin
gemcitabine
docetaxel
cancer chemotherapy
angiosarcoma
soft tissue sarcoma
liposarcoma
undifferentiated pleomorphic sarcoma
leiomyosarcoma
epithelioid sarcoma

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note