Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Sarcoma

Pancreatic Cancer

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Antimetabolites

In Part 1 (dose escalation), participants with selected sarcoma indications will receive escalating doses of ADCT-601 in combination with gemcitabine.

In Part 1 (dose escalation), participants with sarcoma indications (regardless of AXL gene amplification status), non-small-cell lung cancer (NSCLC) (regardless of AXL gene amplification status), and solid tumors with AXL gene amplification, will receive ADCT-601 monotherapy.

In Part 2 (dose expansion), participants with selected sarcoma indications will receive ADCT-601 in combination with gemcitabine.

Participants will be split into 3 cohorts:

Cohorts 5 and 6: Sarcoma indications.

Cohort 7: Pancreatic cancer.

In Part 2 (dose expansion), participants with a selected indication will receive ADCT-601 monotherapy.

Participants will be split into cohorts:

Cohort 1: Soft tissue sarcoma (STS).

Cohort 2: Pancreatic adenocarcinoma (PAAD).

Cohort 3: NSCLC.

Cohort 4: Solid tumors with known AXL expression.

ADCT-601

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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.

A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors

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

Adverse events (AEs) and serious adverse events (SAEs) are defined as any untoward medical occurrence in participants whether or not considered related to the investigational medicinal product. Any clinically significant changes in vital signs, laboratory values, 12-lead electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status results will be recorded as AEs and SAEs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors	NCT05389462	Advanced Solid ...	ADCT-601 Gemcitabine	18 Years -	ADC Therapeutics S.A.
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors	NCT05389462	Advanced Solid ...	ADCT-601 Gemcitabine	18 Years -	ADC Therapeutics S.A.

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