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Telisotuzumab Adizutecan + Combination Therapy for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AbbVie

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Eligibility Criteria

This trial is for adults with metastatic colorectal cancer (mCRC) who have measurable disease, are in good physical condition (ECOG status of 0 or 1), and meet specific laboratory criteria. It's not suitable for those who don't fit these requirements.

Inclusion Criteria

Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.

Laboratory values meeting the criteria within the protocol

I am fully active or can carry out light work.

Exclusion Criteria

I haven't had any other cancers in the last 5 years, except for those unlikely to spread.

I have been treated with drugs targeting c-Met or topoisomerase inhibitors.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until a tolerable and efficacious dose is reached.

Up to 24 weeks

Regular visits (in-person)

Dose Optimization

Participants receive one of two optimized doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab.

Up to 22 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years

Regular visits (in-person)

Participant Groups

The study tests a new drug, Telisotuzumab Adizutecan, combined with chemotherapy drugs FOLFOX and either Bevacizumab or Panitumumab. Participants will first receive increasing doses to find the safest effective amount, then be randomly assigned to treatment groups.

8Treatment groups

Experimental Treatment

Group I: Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low DoseExperimental Treatment4 Interventions

Participants will receive the low dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.

Group II: Substudy 2: Dose Expansion Telisotuzumab Adizutecan High DoseExperimental Treatment4 Interventions

Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.

Group III: Substudy 2: Dose Expansion CompatatorExperimental Treatment4 Interventions

Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration.

Group IV: Substudy 2: Dose Escalation Telisotuzumab AdizutecanExperimental Treatment4 Interventions

Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil (5-FU) and leucovorin (LV) and panitumumab as part of the approximately 6 year study duration.

Group V: Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low DoseExperimental Treatment5 Interventions

Participants will receive the low dose of telisotuzumab adizutecandetermined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Group VI: Substudy 1: Dose Expansion Telisotuzumab Adizutecan High DoseExperimental Treatment5 Interventions

Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Group VII: Substudy 1: Dose Expansion CompatatorExperimental Treatment4 Interventions

Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Group VIII: Substudy 1: Dose Escalation Telisotuzumab AdizutecanExperimental Treatment5 Interventions

Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab as part of the approximately 6 year study duration.