GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)
A Phase 1b/2, Open-label, Multi-center Study to Evaluate the Anti-cancer Activity, Safety and Tolerability of GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig [T-CELL-Redirecting Agent Targeting Human Kallikrein 2 (KLK2)] in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Progressed on Previous Novel Hormonal Therapy (NHT) (JET-201)
The purpose of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination with pasritamig in adult men with metastatic castration-resistant prostate cancer (mCRPC) whose cancer has progressed after previous treatment with a novel hormonal therapy (NHT).
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Kwang-Soo Shin
- Telefonní číslo: +82-2-404-2003
- E-mail: Clinical-102-P201@gi-innovation.com
Studijní místa
-
-
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Seoul, Jižní Korea, 05505
- Nábor
- Asan Medical Center
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Vrchní vyšetřovatel:
- Jae Lyun Lee, M.D., Ph.D.
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Seoul, Jižní Korea, 03722
- Nábor
- Yonsei University Health System, Severance Hospital
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Vrchní vyšetřovatel:
- Sang Joon Shin, M.D., Ph.D.
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-
Banpo-daero
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Seoul, Banpo-daero, Jižní Korea, 06591
- Nábor
- The Catholic University of Korea Seoul ST.MARY'S Hospital
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Vrchní vyšetřovatel:
- In Ho Kim
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Seongbuk-gu
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Seoul, Seongbuk-gu, Jižní Korea, 02841
- Nábor
- Korea University Anam Hospital
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Vrchní vyšetřovatel:
- Jwa Hoon Kim, M.D.
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Yangcheon-gu
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Seoul, Yangcheon-gu, Jižní Korea, 07985
- Nábor
- Ewha Womans University Mokdong Hospital
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Vrchní vyšetřovatel:
- Jeong Min Cho
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-
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New York
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New York, New York, Spojené státy, 10032
- Zatím nenabíráme
- Columbia University Medical Center
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Vrchní vyšetřovatel:
- Mark N. Stein, M.D.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Key Inclusion Criteria:
- Male participants aged ≥18 years (or ≥19 years according to local regulatory requirements).
- ECOG performance status of 0 to 1.
- Histologically confirmed advanced prostate adenocarcinoma with measurable or evaluable disease. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, primary small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma (or pathologic evidence of conversion to) is disallowed.
- Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression following at least one line of novel androgen receptor-targeted therapy.
- PSA ≥2 ng/mL at screening.
- No more than 2 prior taxane regimens and no prior cytotoxic chemotherapy other than taxane therapy.
- Prior orchiectomy or ongoing androgen deprivation therapy with castrate testosterone levels.
- Adequate organ and marrow function and adequate cardiovascular function.
- Adequate recovery from prior anticancer therapy-related adverse events.
- Willingness and ability to comply with study procedures and protocol-specified contraception requirements.
Key Exclusion Criteria:
- Active or prior CNS metastases, carcinomatous meningitis, or clinically unstable spinal cord compression.
- Significant uncontrolled cardiovascular, pulmonary, hepatic, autoimmune, infectious, or other systemic disease.
- Active or recent clinically significant infection, including active tuberculosis, hepatitis B, or hepatitis C.
- Active pneumonitis or interstitial lung disease (ILD), or history of clinically significant pneumonitis/ILD.
- Recent treatment with investigational products, prohibited immunomodulating agents, radiotherapy, major surgery, or other protocol-defined prohibited therapies.
- Prior treatment with CD3-directed therapies, including KLK2-CD3 bispecific antibodies or other CD3-targeting T-cell engagers.
- Known hypersensitivity to GI-102, pasritamig, or their excipients, or any other condition that may interfere with study participation or interpretation of results.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Safety run-in: GI-102 + pasritamig (Schedule A)
Participants receive GI-102 in combination with pasritamig during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design. |
GI-102 will be administered in accordance with the procedures specified in the study protocol. Pasritamig will be administered in accordance with the procedures specified in the study protocol. |
|
Experimentální: Safety run-in: GI-102 + pasritamig (Schedule B)
Participants receive GI-102 in combination with pasritamig during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design. |
GI-102 will be administered in accordance with the procedures specified in the study protocol. Pasritamig will be administered in accordance with the procedures specified in the study protocol. |
|
Experimentální: Expansion
Participants enrolled in the Expansion phase will receive the combination recommended Phase 2 regimen (cRP2R) of GI-102 and pasritamig, determined based on the safety and dose-escalation results from the Safety run-in phase. |
GI-102 will be administered in accordance with the procedures specified in the study protocol. Pasritamig will be administered in accordance with the procedures specified in the study protocol. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence and nature of DLTs (Safety run-in phase)
Časové okno: From Day -14 to Cycle 1 Day 22 (35 days)
|
A DLT is defined as a clinically significant AE (classified according to the NCI CTCAE version 6.0) or significant laboratory abnormality that occur during the DLT assessment periods, and is considered by the Investigator to be related to the study drug(s). |
From Day -14 to Cycle 1 Day 22 (35 days)
|
|
Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Safety run-in phase)
Časové okno: Up to 2 years
|
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. |
Up to 2 years
|
|
PSA response rate (≥ 50% decline from baseline) per PCWG3 (Expansion phase)
Časové okno: Up to 2 years
|
PSA response rate is defined as the percentage of participants with a decline of PSA of 50% or more from baseline. |
Up to 2 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
PSA response rate (≥ 50% and ≥ 90% decline from baseline) per PCWG3 (Safety run-in phase)
Časové okno: Up to 2 years
|
PSA response rate is defined as the percentage of participants with a decline of PSA of 50% (or 90%) or more from baseline. |
Up to 2 years
|
|
Radiographic PFS per PCWG3
Časové okno: Up to 2 years
|
Radiographic PFS is defined as the time from the date of first dose of any study treatment until the date of radiographic disease progression or death, whichever comes first. |
Up to 2 years
|
|
Time to PSA progression
Časové okno: Up to 2 years
|
Time to PSA progression, defined as the time from baseline to the first date of documented PSA progression per PCWG3 criteria. |
Up to 2 years
|
|
Overall Response Rate (ORR) per RECIST v1.1
Časové okno: Up to 2 years
|
Among participants with measurable disease, ORR is defined as the percentage of participants who achieve a partial response (PR) or complete response (CR) according to RECIST v1.1. |
Up to 2 years
|
|
Duration of Response (DoR) per RECIST v1.1
Časové okno: Up to 2 years
|
Among participants with measurable disease who achieve a CR or PR, DoR is defined as the time from the first documented CR or PR until the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first. |
Up to 2 years
|
|
Disease Control Rate (DCR) per RECIST v1.1
Časové okno: Up to 2 years
|
Among participants with measurable disease, DCR is defined as the percentage of participants who achieve a CR, PR, or stable disease (SD) according to RECIST v1.1. |
Up to 2 years
|
|
Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Expansion phase)
Časové okno: Up to 2 years
|
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. |
Up to 2 years
|
|
PK profile: peak plasma concentration (Cmax) of GI-102 when combined with pasritamig
Časové okno: Up to 2 years
|
Plasma concentrations of GI-102 will be measured at specified time points following administration of GI-102 in combination with pasritamig to determine the maximum observed plasma concentration (Cmax). |
Up to 2 years
|
|
PK profile: half-life (T1/2) of GI-102 when combined with pasritamig
Časové okno: Up to 2 years
|
Plasma concentrations of GI-102 will be measured at specified time points following administration of GI-102 in combination with pasritamig to determine the terminal half-life (T1/2) of GI-102. |
Up to 2 years
|
|
PK profile: area under the plasma concentration-time curve (AUC) of GI-102 when combined with pasritamig
Časové okno: Up to 2 years
|
Plasma concentrations of GI-102 will be measured at specified time points following administration of GI-102 in combination with pasritamig to determine the area under the plasma concentration-time curve (AUC) of GI-102. |
Up to 2 years
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Immune cell phenotyping in peripheral blood
Časové okno: Up to 2 years
|
Immune cell populations and their changes following study treatment will be assessed in peripheral blood using flow cytometry. |
Up to 2 years
|
|
Overall Response Rate (ORR) per iRECIST
Časové okno: Up to 2 years
|
ORR is defined as the percentage of participants who achieve a partial response (PR) or complete response (CR) according to the iRECIST criteria. |
Up to 2 years
|
|
Overall Survival (OS)
Časové okno: Up to 2 years
|
Overall survival (OS) is defined as the time from the first dose of study treatment to death from any cause. |
Up to 2 years
|
|
Incidence of anti-GI-102 antibody (ADA)
Časové okno: Up to 2 years
|
Serum samples will be analyzed using a validated assay to determine the incidence of anti-GI-102 antibodies (ADA). |
Up to 2 years
|
|
Incidence of Neutralizing Antibody (Nab) Against GI-102
Časové okno: Up to 2 years
|
Serum samples that are positive for anti-GI-102 antibodies (ADA) will be further analyzed using a validated assay to determine the incidence of neutralizing antibodies (Nab). |
Up to 2 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- GII-102-P201 (JET-201)
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