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.
This is a multicenter, open-label Phase 1-1b study of \[177Lu\]Lu-A9-0631 and \[225Ac\]Ac-A9-0642 in subjects with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors. The study consists of two parts (Phase 1 and 1b). Phase 1 is the dose escalation portion of the study. The aim of the Phase 1 is to evaluate the safety and tolerability as well as the normal organ and tumor dosimetry of \[177Lu\]Lu-A9-0631 and \[225Ac\]Ac-A9-0642, and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Phase 1b will be the dose expansion portion of the study. The aim of the Phase 1b will be to further evaluate the safety, efficacy, and normal organ and tumor dosimetry of \[177 Lu\]Lu-A9-0631 and \[225Ac\]Ac-A9-0642 administered at the RP2D in subjects with (1) Locally advanced, unresectable, or metastatic HR+/HER2- breast cancer; (2) Locally advanced, unresectable, or metastatic prostate cancer; (3) Locally advanced, unresectable, or metastatic CRC; and (4) Other locally advanced, unresectable, or metastatic GRPR-positive solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Administered IV
Administered IV
Administered IV
Administered IV
Melbourne Theranostic Innovation Center
Melbourne N., Victoria, Australia
RECRUITINGGenesisCare Murdoch
Murdoch, Western Australia, Australia
NOT_YET_RECRUITINGPhase 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)
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 treatment
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 treatment
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)
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-A9-0642
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.