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A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

ConditionEndometrial Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAcrivon Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ACR-368

    Drug

    ACR-368 is an experimental drug

  • Gemcitabine

    Drug

    Sensitization of tumor cells is provided through administration of ULDG

  • OncoSignature

    Diagnostic test

    Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy

Treatment groups

350 Participants
are divided into 4 treatment groups
Group A: OncoSignature Positive TumorsExperimental treatment 2 interventions
Group B: OncoSignature Negative TumorsExperimental treatment 3 interventions
Group C: OncoSignature Unselected (Serous All-Comers) ACR-368 with ULDGExperimental treatment 2 interventions
Group D: OncoSignature Unselected (Serous All-Comers) ACR-368Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.

Time frame
Response will be assessed every 8 weeks from baseline through 2 years or death.
2

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

Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.

Time frame
Response will be assessed every 8 weeks from baseline through 2 years or death.
3

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

Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.

Time frame
Response will be assessed every 8 weeks from baseline through 2 years or death.
4

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

Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic

Time frame
Response will be assessed every 8 weeks from baseline through 2 years or death.

Secondary outcomes

1

Arm 1 and Arm 4: Adverse Events (AEs) for ACR-368

Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.

Time frame
AEs will be assessed from baseline through 2 years or death.
2

Arm 2 and Arm 3: Adverse Events (AEs) for ACR-368 with ULDG sensitization

Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.

Time frame
AEs will be assessed from baseline through 2 years or death.
3

All Arms: Limited pharmacokinetic (PK) testing.

Cmax and Tmax will be assessed in the first cycle. Blood samples will be collected at baseline, end of infusion, hour 2 and hour 4.

Time frame
Dose of ACR-368 at day 1 and day 15 of first cycle.
4

Overall Survival (OS)

The time from date of enrollment until date of death.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Acrivon Therapeutics

Lead sponsor

GOG Foundation

Collaborator

Source ClinicalTrials.gov
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