RecruitingPhase 2

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

United States401 participantsStarted 2022-08-29

Plain-language summary

This is an open label Phase 2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or with ultra-low dose gemcitabine (ULDG) sensitization in participants with endometrial cancer.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant must be able to give signed, written informed consent.
✓. Participant must have histologically documented, high-grade endometrial cancer.
✓. All high-grade epithelial endometrial histological subtypes are eligible including: endometrioid (all Grade 3), serous, carcinosarcomas, clear-cell carcinoma, and mixed histologies.
✓. Serous carcinoma or mixed tumors with a majority component of serous carcinoma or carcinosarcoma where the carcinomatous component is serous carcinoma.
✓. Treatment History Requirements:
✓. Subject must have received prior platinum-based chemotherapy
✓. Subject must have received prior anti-PD-(L)1 therapy
✓. Subject must not have received more than three lines of prior systemic therapy Arms 3 and 4

Exclusion criteria

✕. Participant with known symptomatic brain metastases requiring \> 10 mg/day of prednisolone (or its equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment.
✕. Participant has mesenchymal tumors of the uterus.
✕. Participant has a history of clinically meaningful ascites, defined as history of paracentesis or thoracentesis with therapeutic intent, within 4 weeks of Screening. Subjects with planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing are excluded.
✕. Participant had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
✕. Participants has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in Appendix 2.
✕. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis.
✕. Participant has cardiovascular disease, defined as:
✕. Uncontrolled hypertension defined as blood pressure \> 160/90 mmHg at Screening confirmed by repeat (medication permitted).

What they're measuring

Arm 1: Anti-tumor activity of ACR-368 in Endometrial cancer subjects that are OncoSignature Positive.

Timeframe: Response will be assessed every 8 weeks from baseline through 2 years or death.

Arm 2: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects that are OncoSignature Negative.

Timeframe: Response will be assessed every 8 weeks from baseline through 2 years or death.

Arm 3: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).

Timeframe: Response will be assessed every 8 weeks from baseline through 2 years or death.

Arm 4: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).

Timeframe: Response will be assessed every 8 weeks from baseline through 2 years or death.

Trial details

NCT IDNCT05548296

SponsorAcrivon Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-30

Contact for this trial

Mansoor Raza Mirza, MD

617-207-8976 ACR-368-201ClinicalTrial@acrivon.com

View on ClinicalTrials.gov More Endometrial Adenocarcinoma trials

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant must be able to give signed, written informed consent.
✓. Participant must have histologically documented, high-grade endometrial cancer.
✓. All high-grade epithelial endometrial histological subtypes are eligible including: endometrioid (all Grade 3), serous, carcinosarcomas, clear-cell carcinoma, and mixed histologies.
✓. Serous carcinoma or mixed tumors with a majority component of serous carcinoma or carcinosarcoma where the carcinomatous component is serous carcinoma.
✓. Treatment History Requirements:
✓. Subject must have received prior platinum-based chemotherapy
✓. Subject must have received prior anti-PD-(L)1 therapy
✓. Subject must not have received more than three lines of prior systemic therapy Arms 3 and 4

Exclusion criteria

✕. Participant with known symptomatic brain metastases requiring \> 10 mg/day of prednisolone (or its equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment.
✕. Participant has mesenchymal tumors of the uterus.
✕. Participant has a history of clinically meaningful ascites, defined as history of paracentesis or thoracentesis with therapeutic intent, within 4 weeks of Screening. Subjects with planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing are excluded.
✕. Participant had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
✕. Participants has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in Appendix 2.
✕. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis.
✕. Participant has cardiovascular disease, defined as:
✕. Uncontrolled hypertension defined as blood pressure \> 160/90 mmHg at Screening confirmed by repeat (medication permitted).