128 Participants Needed

ADCT-601 + Gemcitabine for Cancer

Recruiting at 14 trial locations
CA
Overseen ByContact ADC Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: ADC Therapeutics S.A.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot use any other experimental medication within 14 days before starting the study drug.

Is the combination of ADCT-601 and Gemcitabine safe for humans?

Gemcitabine, also known as Gemzar, has been studied in many clinical trials and is generally well tolerated with mild side effects like temporary low blood cell counts, mild nausea, and flu-like symptoms. Serious side effects are rare, but some patients have experienced temporary kidney issues and mild swelling. There is no specific safety data available for ADCT-601 (Mipasetamab Uzoptirine) in combination with Gemcitabine.12345

What makes the drug ADCT-601 + Gemcitabine unique for cancer treatment?

The combination of ADCT-601 (Mipasetamab Uzoptirine) with Gemcitabine is unique because it pairs a novel antibody-drug conjugate with a well-established chemotherapy agent, potentially enhancing the effectiveness against solid tumors by targeting cancer cells more precisely while utilizing Gemcitabine's ability to inhibit DNA synthesis.16789

What data supports the effectiveness of the drug Gemcitabine (Gemzar) in cancer treatment?

Gemcitabine has shown effectiveness in treating various cancers, including non-small-cell lung cancer and pancreatic cancer, with response rates of up to 54% when combined with other drugs like cisplatin. It has also been effective in breast, bladder, ovarian, and head and neck cancers, often with mild side effects.1271011

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors, including various sarcomas and cancers like ovarian, pancreatic, bladder, cervical, and endometrial. Participants must have measurable disease and be in good physical condition (ECOG 0-1). They should not respond to standard treatments anymore. People can't join if they've had recent serious infections, chronic diarrhea conditions, symptomatic brain metastases or require frequent drainage for fluid accumulation.

Inclusion Criteria

I am fully active or can carry out light work.
My sarcoma diagnosis does not depend on AXL gene status.
I have previously been treated with a medication that includes gemcitabine.
See 13 more

Exclusion Criteria

I have brain metastases but have been treated and stable for over 4 weeks.
I have moderate diarrhea or a condition like IBS or IBD.
I haven't had an infection needing IV treatment in the last 4 weeks.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ADCT-601 monotherapy and in combination with gemcitabine to determine the maximum tolerated dose

8-12 weeks

Dose Expansion

Participants receive ADCT-601 monotherapy or in combination with gemcitabine to further evaluate safety and efficacy

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Gemcitabine
  • Mipasetamab Uzoptirine (ADCT-601)
Trial Overview The study aims to find the safest dose of a new drug called Mipasetamab Uzoptirine (ADCT-601), both alone and combined with Gemcitabine chemotherapy. Researchers want to see how well patients tolerate these drugs and what effects they have on different types of solid tumors.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Part 2: Dose Expansion, ADCT-601 MonotherapyExperimental Treatment1 Intervention
Group II: Part 2: Dose Expansion, ADCT-601 Combination TherapyExperimental Treatment2 Interventions
Group III: Part 1: Dose Escalation, ADCT-601 MonotherapyExperimental Treatment1 Intervention
Group IV: Part 1: Dose Escalation, ADCT-601 Combination TherapyExperimental Treatment2 Interventions

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Gemzar for:
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Approved in United States as Gemzar for:
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Approved in Canada as Gemzar for:
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Approved in Japan as Gemzar for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

ADC Therapeutics S.A.

Lead Sponsor

Trials
32
Recruited
2,700+

Published Research Related to This Trial

Gemcitabine, a nucleoside analog, inhibits DNA synthesis and shows potential synergy with other antimetabolites like 5-fluorouracil, making it a promising treatment for solid tumors.
In a phase I study involving eight patients, the main side effect observed was myelosuppression, and the study aims to establish the maximum tolerated doses of gemcitabine when combined with UFT and oral calcium folinate.
Gemcitabine and UFT plus oral calcium folinate: phase I study.Philip, PA., Ibrahim, D., Zalupski, M., et al.[2022]
Gemcitabine (GEMZAR) has shown to be an effective treatment for non-small-cell lung cancer (NSCLC) with a response rate of about 21% as a single agent, and it has a mild toxicity profile, making it suitable for combination therapies.
When combined with cisplatin, gemcitabine achieved higher response rates ranging from 38% to 54% and median survival times of 8.4 to 14.3 months, with manageable side effects, indicating its potential as a preferred treatment option in NSCLC.
Combination studies with gemcitabine in the treatment of non-small-cell lung cancer.Steward, WP.[2022]
Gemcitabine is an effective treatment for various solid tumors, including non-small-cell lung cancer and pancreatic cancer, with promising results also seen in breast and bladder cancers, based on phase II studies.
The drug has a favorable side-effect profile and may enhance the effectiveness of other DNA-damaging agents, suggesting its potential for use in combination therapies and different treatment schedules.
The role of gemcitabine in the treatment of other tumours.Carmichael, J.[2022]

Citations

Gemcitabine and UFT plus oral calcium folinate: phase I study. [2022]
Combination studies with gemcitabine in the treatment of non-small-cell lung cancer. [2022]
The role of gemcitabine in the treatment of other tumours. [2022]
Gemcitabine and paclitaxel in metastatic breast cancer: a review. [2022]
Gemcitabine and platinum-based chemotherapy in metastatic breast cancer. [2022]
Gemcitabine--a safety review. [2022]
Efficacy and safety of gemcitabine-fluorouracil combination therapy in the management of advanced pancreatic cancer: a meta-analysis of randomized controlled trials. [2022]
Antitumour activity of sunitinib in combination with gemcitabine in experimental pancreatic cancer. [2022]
[Gemcitabine: from preclinic to clinic passing by pharmacokinetics]. [2022]
Cross-resistance in the 2',2'-difluorodeoxycytidine (gemcitabine)-resistant human ovarian cancer cell line AG6000 to standard and investigational drugs. [2022]
Increased sensitivity to gemcitabine of P-glycoprotein and multidrug resistance-associated protein-overexpressing human cancer cell lines. [2022]
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