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GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer

ConditionPlatinum-resistant Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About this trial

This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age

Patients must have epithelial ovarian, peritoneal, or fallopian tube cancer that is confirmed by histology or cytology, with a histopathological diagnosis of serous, clear cell, endometrioid, mucinous carcinoma, or carcinosarcoma.

Progression of disease within 6 months of last platinum-based chemotherapy, OR

Patients who have an intolerance for further platinum-based therapy.

Disqualifiers

Recent significant bleeding, defined as a history of Grade ≥2 hemorrhage within 30 days before Screening.

Activated partial thromboplastin time (aPTT) >1.5 × ULN. Exception: Participants on therapeutic heparin may be allowed if aPTT is between 1.5 and 2.5 × ULN.

International Normalized Ratio (INR) >1.5. Exception: Participants on warfarin are allowed if INR is between 2.0 and 3.0 on two consecutive measurements taken 1-4 days apart.

Anticoagulant use: Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes is excluded. Prophylactic anticoagulation (e.g., low-molecular-weight heparin [LMWH] 40 mg/day) or use of anticoagulants for venous access device patency is permitted if the participant has been on a stable dose for ≥4 weeks without bleeding complications.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GB-5267 - IV only

    Biological/Vaccine

    IV infusion

  • GB-5267 -Combined IV and IP Infusion

    Biological/Vaccine

    IV and IP Infusion

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: IV OnlyExperimental treatment 1 intervention
Group B: Dose Expansion with Combined IV and IP InfusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD) - Cohort A

Determine the MTD by assessing the incidence of dose limiting toxicities (DLTs) of GB-5267

Time frame
28 days from GB-5267 cell infusion
2

Number of DLTs in combined IV and IP infusions of GB-5267 - Cohort B

Evaluated using the Clopper-Pearson method

Time frame
Day 0 through day 7 after GB-5267 infusion

Secondary outcomes

1

Time to Response - Cohort A

Will be summarized using Kaplan-Meier estimators

Time frame
From start of treatment to first observation of overall response -Up to 2 years
2

Time to Response - Cohort B

Will be summarized using Kaplan-Meier estimators

Time frame
Up to 2 years
3

Duration of Response - Cohort A

Will be summarized using Kaplan-Meier estimators

Time frame
From time of overall response to disease progression or death -Up to 2 years
4

Duration of Response - Cohort B

Will be summarized using Kaplan-Meier estimators

Time frame
rom time of overall response to disease progression or death -Up to 2 years

Other outcomes

Sponsors and contacts

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

Roswell Park Cancer Institute

Lead sponsor

Generate Biomedicines

Collaborator

Source ClinicalTrials.gov
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