DB-1311 + BNT327/DB-1305 for Solid Tumors

Recruiting at 14 trial locations

Overseen By Qiaoli Jiang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: DualityBio Inc.

Must not be taking: B7H3 therapy, Topoisomerase inhibitors

Disqualifiers: Cardiovascular disease, 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: 12-24 weeks

440 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires an adequate treatment washout period (time without taking certain medications) before starting the trial treatment, but it does not specify which medications need to be stopped. It's best to discuss your current medications with the trial team to understand what changes might be necessary.

What makes the drug DB-1311 + BNT327/DB-1305 unique for treating solid tumors?

The drug DB-1311 + BNT327/DB-1305 is unique because it combines multiple components that may work together to target solid tumors more effectively, potentially offering a novel approach compared to standard treatments. This combination could provide a new option for patients with solid tumors, especially if there are limited existing treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors, including uterine tumors. Participants must have a life expectancy of at least 3 months, be in good physical condition (ECOG score 0-1), and have proper organ function. They should not have had certain prior treatments like B7H3 targeted therapy or topoisomerase inhibitor antibody-drug conjugates.

Inclusion Criteria

Has a life expectancy of ≥ 3 months

I am fully active or can carry out light work.

My organs are functioning well enough for me to join a study.

Exclusion Criteria

I have serious heart problems that are not under control.

I have been treated with B7H3 targeted therapy before.

I have been treated with a specific cancer drug linked to a toxin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating combination dose levels of DB-1311/BNT324 and either BNT327 or DB-1305/BNT325 to define RP2D and RP2D-1 in the target population

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• BNT327
• DB-1305/BNT325
• DB-1311

Trial Overview The study tests DB-1311 combined with either BNT327 or DB-1305 on participants with advanced solid tumors. It's an open-label Phase II trial, meaning both the researchers and participants know which treatment is being administered.

Participant Groups

Group I: Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327 Experimental Treatment 2 Interventions

In participants with unresectable advanced/metastatic melanoma

Group II: Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325 Experimental Treatment 2 Interventions

In participants with advanced/unresectable metastatic NSCLC

Group III: Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 and RP2D-1 of DB-1311/BNT324 + BNT327 Experimental Treatment 2 Interventions

In participants with recurrent/metastatic HNSCC

Group IV: Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327 Experimental Treatment 2 Interventions

In participants with unresectable advanced/ metastatic cervical cancer (CC)

Group V: Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327 Experimental Treatment 2 Interventions

In participants with unresectable advanced/metastatic HCC

Group VI: Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy Experimental Treatment 2 Interventions

Escalating combination dose levels of DB-1311/BNT324 and DB-1305/BNT325 to define RP2D and RP2D-1 in target population.

Group VII: Part 1 Cohort 1, DB-1311/BNT324+ BNT327 combination therapy Experimental Treatment 2 Interventions

Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D and RP2D-1 in target population.

Who Is Running the Clinical Trial?

DualityBio Inc.

Lead Sponsor

Trials

12

Recruited

5,800+

BioNTech SE

Industry Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Findings from Research

In a phase II study involving 115 patients with metastatic breast cancer who had previously received anthracycline treatment, the combination of oral vinorelbine and capecitabine demonstrated a promising objective response rate of 56.5%, with 19.1% achieving a complete response.

The treatment was well tolerated, with only 0.8% of patients experiencing febrile neutropenia, and resulted in a median progression-free survival of 10.5 months and a median overall survival of 17.5 months, indicating both efficacy and safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of oral vinorelbine and capecitabine in anthracycline pretreated patients with metastatic breast cancer. Finek, J., Holubec, L., Svoboda, T., et al.[2022]

In a study of 42 patients with advanced non-small cell lung cancer (NSCLC), the combination of navelbine (NVB) and cisplatin (DDP) resulted in a partial response rate of 47.6%, indicating significant efficacy in treating this cancer.

The treatment was associated with manageable toxicity, primarily neutropenia, affecting 66.6% of patients, while also showing that higher doses of NVB led to better response rates, suggesting a dose-response relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Navelbine plus cisplatin combination therapy in the treatment of advanced non-small cell lung cancer: a report of 42 cases]. Zhang, X., Sun, Y., Kong, W.[2018]

References

1. Greece pubmed.ncbi.nlm.nih.gov

A phase II trial of oral vinorelbine and capecitabine in anthracycline pretreated patients with metastatic breast cancer. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Navelbine plus cisplatin combination therapy in the treatment of advanced non-small cell lung cancer: a report of 42 cases]. [2018]

3. China pubmed.ncbi.nlm.nih.gov

[Comparison of navelbine plus ifosfamide and cisplatin versus ifosfamide plus cisplatin in the treatment of advanced non small cell lung cancer]. [2011]

4. Japan pubmed.ncbi.nlm.nih.gov

[Antitumor activity of navelbine (vinorelbine ditartrate), a new vinca alkaloid analog]. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Weekly vinorelbine versus docetaxel for metastatic breast cancer after failing anthracycline treatment. [2018]