Leronlimab + Standard Treatment for Colorectal Cancer

Recruiting at 6 trial locations

Overseen By Patrick Vittner

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CytoDyn, Inc.

Must not be taking: Anabolic steroids

Disqualifiers: Coronary heart disease, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding leronlimab, an experimental treatment, to standard therapies can improve the response in individuals with colorectal cancer that has spread after previous treatments. Researchers aim to determine if leronlimab is safe and effective in shrinking the cancer or preventing its growth. The study seeks participants with metastatic colorectal cancer who have already undergone specific chemotherapy treatments. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in cancer treatment.

Do I have to stop taking my current medications to join the trial?

The trial requires that you have not had any anti-cancer treatment within the last four weeks or at least 5 half-lives before starting the study, except for certain radiation therapy. It doesn't specify about other medications, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown promising safety results for leronlimab. In one study with 30 patients, leronlimab combined with another cancer drug was generally well-tolerated, meaning patients did not experience unexpected serious side effects. Another report indicated that 3 out of 5 patients showed a partial response to the treatment, suggesting it was not only safe but also potentially effective.

Leronlimab is currently being tested with other standard cancer treatments like trifluridine, tipiracil, and bevacizumab. These commonly used drugs have well-known safety profiles from previous research. The current study is in its early to mid-phase, focusing on ensuring safety and determining the right dose. So far, previous research indicates that leronlimab is safe when used with these drugs, with no serious safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about leronlimab for colorectal cancer because it offers a fresh approach by targeting the CCR5 receptor, which plays a role in cancer cell migration and invasion. Unlike the traditional chemotherapy options like FOLFOX or FOLFIRI, which primarily target rapidly dividing cells, leronlimab is designed to modulate the immune system and potentially slow down tumor progression. Additionally, when combined with Trifluridine/Tipiracil (TAS-102) and Bevacizumab, leronlimab may enhance the efficacy of these existing treatments, offering a potentially more powerful therapeutic option for patients.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research has shown that leronlimab might help treat advanced colorectal cancer. In an earlier study, three out of five patients demonstrated at least some improvement when taking leronlimab, as seen in imaging tests. Remarkably, one patient experienced a complete recovery that lasted five years. These results suggest that leronlimab could benefit some people with advanced colorectal cancer. In this trial, participants will receive either a 350 mg or 700 mg dose of leronlimab in combination with standard treatments like trifluridine, tipiracil, and bevacizumab. The treatment blocks a protein called CCR5, which plays a role in cancer spread. This gives hope that leronlimab could improve outcomes when used with these standard treatments. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with colorectal cancer that has spread and can't be removed by surgery. They must have tried other treatments, including chemotherapy and anti-VEGF or anti-EGFR therapy if suitable. Participants need to show CCR5+ in their tumors, have stable health (ECOG 0 or 1), measurable disease per RECIST 1.1, no recent cancer treatment except palliative radiation, and an expected survival of at least three months.

Inclusion Criteria

I am HIV positive with a viral load under 50 copies/ml and have been on stable ART for 3+ months.

Demonstrate positive tumor expression of CCR5 by IHC

Have measurable disease per RECIST 1.1

Exclusion Criteria

Known severe hypersensitivity towards monoclonal antibodies

I do not have serious heart disease or very low blood pressure.

Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive leronlimab in combination with trifluridine and tipiracil + bevacizumab

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Leronlimab

Trial Overview The study tests two doses of leronlimab (700 mg and 350 mg) combined with trifluridine/tipiracil + bevacizumab in patients with metastatic colorectal cancer who've progressed after prior treatments. It's designed to see if this combination improves response rates/survival times compared to standard care alone and assess its safety.

How Is the Trial Designed?

Group I: 700 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab Experimental Treatment 1 Intervention

700 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab

Group II: 350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab Experimental Treatment 1 Intervention

350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab

Who Is Running the Clinical Trial?

CytoDyn, Inc.

Lead Sponsor

Trials

25

Recruited

2,600+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06699836

A Phase 2 Study of Leronlimab in Combination With TAS- ... This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety ...

2. cytodyn.com cytodyn.com/newsroom/press-releases/detail/642/cytodyn-announces-encouraging-survival-data-in-patients

CytoDyn Announces Encouraging Survival Data in Patients ... The final results indicate that 3/5 patients treated with leronlimab had at least a partial response, as measured by radiologic criteria.

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)00349-7/pdf

134eP Observed survival following treatment with ... Results: We analyzed data from 94 patients (49% male), with a mean age of 63 (32-. 85). Thirty-four percent had right-sided colon cancer, 42% left-sided colon ...

4. curetoday.com curetoday.com/view/leronlimab-shows-activity-in-advanced-metastatic-colorectal-cancer

Leronlimab Shows Activity in Advanced Metastatic ... Three of five patients with advanced colorectal cancer responded to leronlimab, including one complete response lasting five years, according to new data.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05730673?term=AREA%5BConditionSearch%5D(colorectal%20cancer)%20AND%20AREA%5BInterventionSearch%5D(leronlimab)&rank=2

Study Details | NCT05730673 | Leronlimab in Combination ... This ia a phase II, single arm study with 30 patients in order to test the hypothesis that the combination of Leronlimab (PRO 140) SC and oral Regorafenib ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/557035

A Phase 2 Study of Leronlimab in Combination With TAS- ... This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130001b.pdf

summary of safety and effectiveness data (ssed) The Epi proColon test is predicated on the observation that cancer specific DNA can be detected in the blood of individuals with colorectal ...