A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha-9 Oncology USA Inc.
About this trial
This is a Phase 1-1b multicenter clinical study to evaluate the safety, efficacy, and dosimetry of \[177Lu\]Lu-A9-0631 and \[225Ac\]Ac-0642 in participants with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has provided written informed consent prior to any study-specific procedure.
Age ≥ 18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Have measurable target lesion per RECIST v1.1.
Disqualifiers
Received anticancer treatment including but not limited to chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior (≤ 28 days prior in case of checkpoint inhibitor therapy and other antibody therapies) or 5 half-lives, (t1/2) whichever is shorter, to the administration of therapeutic investigational product.
History of uncontrolled allergic reactions and/or known or expected hypersensitivity to a peptide-based imaging or therapeutic agent or any excipient present in either of the therapeutic investigational products.
Major surgery within 4 weeks of planned first dose of the therapeutic investigational product.
Prior external beam radiation therapy to more than 25% of the bone marrow.
Trial design
Design model
Parallel
Treatments tested in this trial
[68Ga]Ga-A9-6217
Diagnostic testAdministered IV
Low dose [177Lu]Lu-A9-0631
Diagnostic testAdministered IV
[177Lu]Lu-A9-0631
DrugAdministered IV
[225Ac]Ac-A9-0642
DrugAdministered IV
Treatment groups
115 Participants
are divided into 2 treatment groupsGroup A: Phase 1 Dose EscalationExperimental treatment 4 interventions
Group B: Phase 1B Dose ExpansionExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.
Time frame
From the first dose of study drug up to the End of Treatment (30 days after the last dose)2
Phase 1: Number of Patients with Dose-Limiting Toxicities (DLTs).
DLTs is defined as any predefined AE occurring during the DLT observation period.
Time frame
Up to 28 days following first study treatment3
Phase 1: Maximum tolerated dose (MTD)
Incidence of dose-limiting toxicity (DLT) per dose level of \[177Lu\]Lu-A9-0631 and/or \[225Ac\]Ac-A9-0642.
Time frame
Up to 28 days following first study treatmentSecondary outcomes
1
Phase 1-1b: Absorbed dose estimates (Gy) in normal organs for [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642
Time frame
Up to 7 days after each injection for up to 6 cycles (each cycle is 28 days)2
Phase 1-1b: Objective Response Rate (ORR)
Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST 1.1, by dose level.
Time frame
Every 8 ± 1 weeks until radiographic disease progression or up to 12 months after the last dose of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov