260 Participants Needed

CBP-1019 for Advanced Cancers

Recruiting at 4 trial locations
BP
JX
Overseen ByJay X Ma
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Coherent Biopharma (Hefei) Co., Ltd.
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?

This trial is testing CBP-1019, a drug that targets cancer cells, in patients with advanced solid tumors who have no other treatment options. The drug works like a guided missile, finding and attacking cancer cells more precisely.

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, it mentions that washout periods of prior anti-tumor treatments must be completed, which might imply stopping certain cancer treatments before starting the trial.

What safety data exists for CBP-1019 or similar treatments?

The research on similar treatments like EC131 and EC1456 shows they were effective in targeting tumors without causing significant toxicity in animal models. Additionally, exatecan mesylate, a component of CBP-1019, was studied in humans to determine safe dosage levels, although specific safety data for CBP-1019 itself is not provided.12345

What makes the drug CBP-1019 unique for treating advanced cancers?

CBP-1019 is unique because it targets cancer cells that overexpress folate receptors, using a folate-peptide conjugate to deliver the drug directly to the tumor, potentially reducing side effects and increasing effectiveness compared to non-targeted therapies.12678

What data supports the effectiveness of the drug CBP-1019 for advanced cancers?

Research on similar folate-linked drug conjugates shows they can effectively target cancer cells that overexpress folate receptors, leading to significant tumor reduction in preclinical models. This suggests that CBP-1019, which uses a similar targeting mechanism, may also be effective in treating advanced cancers.12679

Who Is on the Research Team?

Lin SHEN

Lin Shen

Principal Investigator

Peking University Cancer Hospital & Institute

Are You a Good Fit for This Trial?

Adults over 18 with advanced solid tumors, including lung, pancreatic, colorectal, esophageal, and breast cancer. They must have tried standard treatments or be unsuitable for them. Participants need a life expectancy of at least 3 months and good performance status (able to carry out daily activities). Tumor tissue is required for testing specific receptors. Women who can bear children and men with partners who can must use approved contraception.

Inclusion Criteria

My cancer has grown after my last treatment.
My organs and bone marrow are working well.
I can provide a tumor sample for specific testing if I choose a low dose treatment.
See 7 more

Exclusion Criteria

I have had a fever over 38.5°C without knowing why.
I have an active Hepatitis B infection with specific virus levels.
I haven't had any cancer other than early-stage skin or superficial bladder cancer in the last 5 years.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase Ia)

Participants receive CBP-1019 IV infusion every 2 weeks to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)

28 days
Every 2 weeks

Treatment (Phase Ib/II)

Participants receive RP2D CBP-1019 IV infusion every two weeks until disease progression or intolerability

Up to 12 months
Every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CBP-1019
Trial Overview The trial tests CBP-1019's safety and effectiveness in treating various advanced cancers. It aims to find the best dose for phase II trials. Patients will receive CBP-1019 to see how well it works against their cancer and what side effects it may cause.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Coherent Biopharma (Hefei) Co., Ltd.

Lead Sponsor

Trials
1
Recruited
260+

Published Research Related to This Trial

Eight new drug conjugates combining a camptothecin derivative (Namitecan) with RGD peptides were developed to enhance drug delivery to tumors, focusing on optimizing the drug-linkage for better performance.
Among the tested conjugates, C6 and C7 demonstrated strong receptor affinity, good stability in blood, and high cytotoxicity against tumor cells, with an IC₅₀ of 8 nM, indicating their potential as effective cancer treatments.
Conjugates of a novel 7-substituted camptothecin with RGD-peptides as α(v)β₃ integrin ligands: An approach to tumor-targeted therapy.Dal Pozzo, A., Esposito, E., Ni, M., et al.[2017]
Folic acid (FA) can effectively target folate receptors (FRs) that are often overexpressed in various cancer cells, making it a promising tool for delivering anticancer drugs like methotrexate (MTX).
The new FA-AG-GFLG-MTX drug conjugate showed a 6.3-fold increase in cytotoxic activity against FR-overexpressing cancer cells compared to those lacking FR, demonstrating its potential for targeted cancer therapy.
Arabinogalactan-folic acid-drug conjugate for targeted delivery and target-activated release of anticancer drugs to folate receptor-overexpressing cells.Pinhassi, RI., Assaraf, YG., Farber, S., et al.[2016]
EC1456 is a highly specific folate-tubulysin conjugate that shows approximately 1000-fold specificity against folate receptor-positive cancer cells, demonstrating effective dose-responsive activity in preclinical models.
In studies with nude mice bearing FR-positive human tumors, EC1456 not only cured 100% of the mice at non-toxic doses but also enhanced the effectiveness of standard chemotherapy agents, suggesting its potential as a powerful treatment option for resistant cancer types.
Pre-clinical evaluation of EC1456, a folate-tubulysin anti-cancer therapeutic.Reddy, JA., Dorton, R., Bloomfield, A., et al.[2019]

Citations

Conjugates of a novel 7-substituted camptothecin with RGD-peptides as α(v)β₃ integrin ligands: An approach to tumor-targeted therapy. [2017]
Arabinogalactan-folic acid-drug conjugate for targeted delivery and target-activated release of anticancer drugs to folate receptor-overexpressing cells. [2016]
Pre-clinical evaluation of EC1456, a folate-tubulysin anti-cancer therapeutic. [2019]
Folate receptor-specific antitumor activity of EC131, a folate-maytansinoid conjugate. [2021]
Targeted Delivery of Cabazitaxel Using Cyclic Cell-Penetrating Peptide and Biomarkers of Extracellular Matrix for Prostate and Breast Cancer Therapy. [2021]
Phase I and pharmacokinetic study of exatecan mesylate (DX-8951f): a novel camptothecin analog. [2017]
Antigen-independent tumor targeting by CBX-12 (alphalex™-exatecan) induces long-term antitumor immunity. [2023]
Therapeutic efficacy of folate receptor-targeted amphiphilic cyclodextrin nanoparticles as a novel vehicle for paclitaxel delivery in breast cancer. [2022]
[Application of Asn-Gly-Arg sequence based cyclic peptides for targeted tumor therapy]. [2022]
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