CR-001 for Cancer
(ASCEND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called CR-001, a potential drug for individuals with advanced or spreading solid tumors, such as liver, lung, or ovarian cancer. The primary goal is to determine the safety of CR-001 and identify the optimal dose for future studies. The trial includes different groups to test various doses and assess patient tolerance. Suitable candidates have either tried other treatments without success or were unable to receive them and have one of the specified cancer types. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
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, if you are on systemic steroid therapy or have an active autoimmune disease requiring treatment, you may not be eligible to participate.
Is there any evidence suggesting that CR-001 is likely to be safe for humans?
Research shows that CR-001 is a promising new treatment being tested for cancer. CR-001 is a special type of protein designed to find and attack cancer cells. Early studies have focused on assessing the safety of CR-001 for people.
Initial results suggest that CR-001 is generally well-tolerated, with most participants not experiencing serious side effects. However, as with any new treatment, some side effects can occur. These studies aim to determine the best dose that is both safe and effective.
Since the trial is in its early stages, researchers are closely monitoring the treatment to ensure its safety for larger groups. Prospective participants should know that safety checks are a major focus at this stage.12345Why do researchers think this study treatment might be promising?
Researchers are excited about CR-001 for cancer treatment because it offers a new approach for patients with advanced or hard-to-treat solid tumors. Unlike traditional chemotherapy, which often attacks both cancerous and healthy cells, CR-001 aims to specifically target cancer cells, potentially reducing side effects. This treatment is particularly promising for patients who have exhausted standard options or cannot tolerate them, as it explores different dosing strategies to find the most effective and tolerable levels. By focusing on personalized treatment regimens, CR-001 could pave the way for more tailored cancer therapies.
What evidence suggests that CR-001 might be an effective treatment for cancer?
Research has shown that CR-001 has promising results in early studies for treating solid tumors. In lab tests, CR-001 effectively reduced tumors and proved safe for animals. These findings suggest that CR-001 might also help shrink tumors in humans. Although information from human studies remains limited, the early results encourage further research into CR-001 as a potential cancer treatment. Participants in this trial will receive CR-001 in various treatment arms, including dose escalation and dose optimization cohorts, to further evaluate its safety and effectiveness.12678
Who Is on the Research Team?
Brad Sumrow, MD
Principal Investigator
Crescent Biopharma, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with advanced or widespread solid tumors, such as pancreatic cancer. Participants should be able to receive the experimental treatment CR-001 and have not found success with other treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CR-001 with dose escalation, backfill, and dose optimization over a period of up to 2 years
Safety Follow-up
Participants are monitored for safety, including disease assessment scans and laboratory tests
Long-term Follow-up
Long-term efficacy and survival follow-up conducted by telephone every 3 months
What Are the Treatments Tested in This Trial?
Interventions
- CR-001
Trial Overview
The study is testing the safety of a new therapy called CR-001 on its own. It aims to find the highest dose patients can take without serious side effects and determine an effective dose for future studies.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Escalating dose levels of CR-001 to define the maximum tolerated dose of CR-001 in participants with locally advanced or metastatic solid tumors who are refractory to or unable to tolerate standard of care treatment, or for whom standard of care treatment is unavailable
monotherapy DL-Y Indication-specific cohort populations will be tested
monotherapy dose level (DL)-X Indication-specific cohort populations will be tested
Escalating dose levels of CR-001 Indication-specific cohort populations will be tested
Find a Clinic Near You
Who Is Running the Clinical Trial?
Crescent Biopharma, Inc.
Lead Sponsor
Citations
CR-001 in Adult Participants With Locally Advanced or ...
The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), ...
2.
investors.crescentbiopharma.com
investors.crescentbiopharma.com/news-releases/news-release-details/crescent-biopharma-announces-regulatory-clearances-indRelease Details
ASCEND, a global Phase 1/2 trial of CR-001 in patients with solid tumors, is anticipated to commence in the first quarter of 2026.
1185 Preclinical development of CR-001, a novel ...
In vivo, CR-001 demonstrated potent anti-tumor activity, and was well-tolerated in cynomolgus monkeys after a single intravenous dose with peak ...
4.
cancernetwork.com
cancernetwork.com/view/phase-1-study-evaluating-jnj-80038114-in-metastatic-crpc-discontinues-earlyPhase 1 Study Evaluating JNJ-80038114 in Metastatic ...
“Although this first-in-human study demonstrated a manageable safety profile of JNJ-80038114, the lack of antitumor activity and the ...
Real-world clinical utility of comprehensive genomic ...
Comprehensive genomic profiling reveals a unique genomic landscape in solid tumors in an Indian cancer cohort of 1000 patients: a single ...
6.
ctv.veeva.com
ctv.veeva.com/study/cr-001-in-adult-participants-with-locally-advanced-or-metastatic-solid-tumorsCR-001 in Adult Participants With Locally Advanced or ...
The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), ...
7.
trial.medpath.com
trial.medpath.com/clinical-trial/4dec28ff5b39d634/nct07335497-cr-001-solid-tumors-safety-efficacyCR-001 in Adult Participants With Locally Advanced or ...
The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), ...
8.
investors.crescentbiopharma.com
investors.crescentbiopharma.com/news-releases/news-release-details/crescent-biopharma-present-preclinical-data-cr-001-pd-1-x-vegfCrescent Biopharma to Present Preclinical Data for CR- ...
CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated ...
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