Informations générales (source: ClinicalTrials.gov)
A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors
Interventional
Phase 1
ADC Therapeutics S.A. (Voir sur ClinicalTrials)
juillet 2022
août 2027
15 août 2024
The primary objective of this study is to identify the recommended phase 2 dose (RP2D)
and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of
ADCT-601 monotherapy and in combination with gemcitabine.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:37 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33076 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Institut Léon Bérard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Male or female participant aged 18 years or older.
2. Pathologic diagnosis of solid tumor malignancy that is locally advanced or
metastatic at time of screening:
Part 1:
1. Combination therapy arms: Selected sarcoma indications from the following 2
separate categories.
- Soft tissue sarcoma: leiomyosarcoma, liposarcoma, undifferentiated
pleomorphic sarcoma (UPS; covering malignant fibrous histiocytoma) and
synovial sarcoma.
- Bone sarcoma: Ewing's sarcoma (including extraskeletal), osteosarcoma, and
chondrosarcoma.
2. Monotherapy arms:
- Sarcoma indications (including those listed for combination therapy arms)
regardless of AXL gene amplification status.
- NSCLC regardless of AXL gene amplification status.
- Solid tumors (lymphomas participants are excluded) with known AXL gene
amplification.
Part 2:
1. Combination therapy arms: Sarcoma indications and PAAD.
2. Monotherapy arms: PAAD, NSCLC and solid tumors with AXL expression.
3. Participants who are refractory to or intolerant to available standard therapy(ies)
known to provide clinical benefit for their condition per Investigator judgment.
4. Participants with measurable disease as determined by Response Evaluation Criteria
in Solid Tumors (RECIST) v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
6. PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1.
1. Male or female participant aged 18 years or older.
2. Pathologic diagnosis of solid tumor malignancy that is locally advanced or
metastatic at time of screening:
Part 1:
1. Combination therapy arms: Selected sarcoma indications from the following 2
separate categories.
- Soft tissue sarcoma: leiomyosarcoma, liposarcoma, undifferentiated
pleomorphic sarcoma (UPS; covering malignant fibrous histiocytoma) and
synovial sarcoma.
- Bone sarcoma: Ewing's sarcoma (including extraskeletal), osteosarcoma, and
chondrosarcoma.
2. Monotherapy arms:
- Sarcoma indications (including those listed for combination therapy arms)
regardless of AXL gene amplification status.
- NSCLC regardless of AXL gene amplification status.
- Solid tumors (lymphomas participants are excluded) with known AXL gene
amplification.
Part 2:
1. Combination therapy arms: Sarcoma indications and PAAD.
2. Monotherapy arms: PAAD, NSCLC and solid tumors with AXL expression.
3. Participants who are refractory to or intolerant to available standard therapy(ies)
known to provide clinical benefit for their condition per Investigator judgment.
4. Participants with measurable disease as determined by Response Evaluation Criteria
in Solid Tumors (RECIST) v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
6. PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1.
1. History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or
IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).
2. Symptomatic central nervous system (CNS) metastases or evidence of leptomeningeal
disease (brain magnetic resonance imaging [MRI] or previously documented
cerebrospinal fluid [CSF] cytology). Previously treated asymptomatic CNS metastases
are permitted provided that the last treatment (systemic anticancer therapy and/or
local radiotherapy) was completed ≥4 weeks prior to Day 1 except usage of low dose
of steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 and
consecutive days is permissible if being tapered down). Participants with discrete
dural metastases are eligible.
3. Clinically significant third space fluid accumulation (i.e., ascites requiring
drainage or any serosal effusion that is either requiring drainage or associated
with shortness of breath).
4. Active diarrhea Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or a
medical condition associated with chronic diarrhea (such as irritable bowel
syndrome, inflammatory bowel disease).
5. Use of any other experimental medication within 14 days prior to start of study drug
(C1D1).