DB-1310 for Advanced Cancer

Recruiting at 25 trial locations

Overseen By Tiana Zhao

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: DualityBio Inc.

Must not be taking: HER3 therapies, CYP3A4 inducers

Disqualifiers: Heart failure, Myocardial infarction, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new treatment, DB-1310, for individuals with advanced solid tumors. Different groups within the trial focus on specific cancer types, such as non-small cell lung cancer (NSCLC) with certain genetic mutations and HER2-positive breast cancer. The trial is best suited for those whose cancers have worsened despite standard treatments or who have no other treatment options. Participants should have measurable cancer progression and a decent overall health status to qualify. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial protocol does not specify if you must stop taking your current medications. However, you may need to avoid certain drugs that affect the heart's rhythm or those that interact with specific enzymes (CYP3A4). It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that DB-1310 is likely to be safe for humans?

Research has shown that DB-1310 is generally safe. In studies, patients with advanced solid tumors usually tolerated the treatment well. Some common side effects occurred, but they were not severe for most people.

Specifically, patients with advanced non-small cell lung cancer (NSCLC) who took DB-1310 experienced promising results. The side effects were manageable, meaning they were not too harmful and could be controlled.

In animal tests, DB-1310 demonstrated a good safety level, suggesting it might be safe for humans too. Although research is still in its early stages, these findings indicate that DB-1310 is likely safe for humans in controlled settings. However, more studies are needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for advanced cancer, which often involve chemotherapy, radiation, or targeted therapies like Osimertinib or Trastuzumab alone, DB-1310 is unique because it targets specific genetic mutations such as EGFR exon 19 deletion, L858R, and KRAS mutations, alongside HER2-positive and other advanced solid tumors. Researchers are excited about DB-1310 because it combines with existing targeted therapies to potentially enhance their effectiveness, offering a more customized approach to treatment. Additionally, DB-1310's ability to target diverse mutations and work in combination with other drugs may improve outcomes for patients who have progressed after standard treatments. This new approach could lead to more effective management of complex, advanced cancers.

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

Research has shown that DB-1310 may help treat advanced solid tumors. In earlier studies, DB-1310 showed promising results, particularly in patients with non-small cell lung cancer (NSCLC) that has specific genetic changes known as EGFR mutations. One study found that patients treated with DB-1310 lived without their cancer worsening for about 7 months on average, and their overall survival was about 19 months. In this trial, participants will receive DB-1310 in various treatment arms, targeting different cancer types and genetic profiles. DB-1310 targets a protein often found in cancer cells. This targeted approach has shown potential in both lab and early human studies, suggesting it may effectively fight certain cancer types while being generally safe. ^{2 3 6 7 8}

Who Is on the Research Team?

Lily Hu

Principal Investigator

DualityBio Inc.

Are You a Good Fit for This Trial?

Adults (≥18 years) with advanced solid tumors who've tried standard treatments without success or can't tolerate them. They must have a life expectancy of ≥3 months, good organ function, and an ECOG performance status of 0-1. Participants need measurable lesions per RECIST criteria or qualify for Phase 2a Cohort 2c. Women shouldn't be pregnant/breastfeeding and along with men, must use contraception.

Inclusion Criteria

I understand the study's procedures and risks, can consent in writing, and will follow the study requirements.

I agree not to freeze or donate sperm during and for 4 months after the study.

I have at least one tumor that can be measured.

Exclusion Criteria

I have active hepatitis.

I had a heart attack or unstable chest pain in the last 6 months.

Know human immunodeficiency virus (HIV) infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Dose-escalation phase to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of DB-1310 as monotherapy and in combination with other drugs

8 cycles (each cycle is 21 days)

Phase 2a Treatment

Dose-expansion phase to confirm safety, tolerability, and explore efficacy of DB-1310 in selected malignant solid tumors

8 cycles (each cycle is 21 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 1 year post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• DB-1310

Trial Overview DB-1310 is being tested in this Phase 1/2a trial to see how safe it is and how well people with advanced solid tumors can handle different doses. The study will gradually increase the dose (dose-escalation) and then give it to more people at the best dose found (dose-expansion).

How Is the Trial Designed?

Group I: DB-1310 Dose Level 9 Experimental Treatment 2 Interventions

Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab

Group II: DB-1310 Dose Level 8 Experimental Treatment 3 Interventions

Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab

Group III: DB-1310 Dose Level 7 Experimental Treatment 2 Interventions

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W

Group IV: DB-1310 Dose Level 6 Experimental Treatment 2 Interventions

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W

Group V: DB-1310 Dose Level 5 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 5 on Day 1 of each cycle Q3W

Group VI: DB-1310 Dose Level 4 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 4 on Day 1 of each cycle Q3W

Group VII: DB-1310 Dose Level 3 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 3 on Day 1 of each cycle Q3W

Group VIII: DB-1310 Dose Level 2 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 2 on Day 1 of each cycle Q3W

Group IX: DB-1310 Dose Level 13 Experimental Treatment 2 Interventions

Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib

Group X: DB-1310 Dose Level 12 Experimental Treatment 2 Interventions

Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib

Group XI: DB-1310 Dose Level 11 Experimental Treatment 3 Interventions

Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib

Group XII: DB-1310 Dose Level 10 Experimental Treatment 2 Interventions

Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab

Group XIII: DB-1310 Dose Level 1 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W

Group XIV: DB-1310 Dose Expansion 9 Experimental Treatment 1 Intervention

Enrolled subjects with NSCLC with KRAS mutation who will receive DB-1310 on a selected dose level (RP2D)

Group XV: DB-1310 Dose Expansion 8 Experimental Treatment 2 Interventions

Enrolled subjects with NSCLC with EGFR who will receive DB-1310 on a selected dose level in combination with Osimertinib

Group XVI: DB-1310 Dose Expansion 7 Experimental Treatment 2 Interventions

Enrolled subjects with advanced/unresectable, or metastatic non-squamous NSCLC with EGFR exon 19 deletion or L858R mutation who haven't received any treatment in locally advanced, or metastatic disease will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with Osimertinib.

Group XVII: DB-1310 Dose Expansion 6 Experimental Treatment 1 Intervention

Enrolled Subject with other advanced/unresectable, or metastatic solid tumors who have progressed on or after standard systemic treatment, or for which no standard systemic treatment is available will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Group XVIII: DB-1310 Dose Expansion 5 Experimental Treatment 2 Interventions

Enrolled Subjects with advanced/unresectable, or metastatic BC with HER2-positive (IHC3+, or IHC2+ and ISH+) who have progressed on or after HER2 targeted systemic treatments will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with trastuzumab deruxtecan.

Group XIX: DB-1310 Dose Expansion 4 Experimental Treatment 1 Intervention

Enrolled Subjects with advanced/unresectable, or metastatic HNSCC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Group XX: DB-1310 Dose Expansion 3 Experimental Treatment 1 Intervention

Enrolled Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Group XXI: DB-1310 Dose Expansion 2 Experimental Treatment 1 Intervention

Enrolled Subjects with advanced/unresectable, or metastatic NSCLC without EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Group XXII: DB-1310 Dose Expansion 11 Experimental Treatment 1 Intervention

Enrolled subjects with BTC who will receive DB-1310 on a selected dose level (RP2D)

Group XXIII: DB-1310 Dose Expansion 10 Experimental Treatment 1 Intervention

Enrolled subjects with ESCC who will receive DB-1310 on a selected dose level (RP2D)

Group XXIV: DB-1310 Dose Expansion 1 Experimental Treatment 1 Intervention

Enrolled Subjects with advanced/unresectable, or metastatic adenocarcinoma NSCLC with EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Who Is Running the Clinical Trial?

DualityBio Inc.

Lead Sponsor

Trials

12

Recruited

5,800+

Published Research Related to This Trial

Oral chemotherapy options like Xeloda (capecitabine) and oral vinorelbine improve access for patients with metastatic breast cancer, especially when hospital visits are challenging due to financial or logistical reasons.

Combination therapies using taxoids and anthracyclines have increased response rates in first-line treatments, but maintenance regimens with less toxic agents can prolong response duration and improve disease-free survival, making outpatient treatment more feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing chemotherapy for patients with advanced breast cancer. Marty, M., Espie, M., Cottu, PH., et al.[2017]

The combination of docetaxel and capecitabine was found to be effective in treating anthracycline-resistant metastatic breast cancer, achieving an overall response rate of 46.9% among 32 patients, with a median time to progression of 5.6 months.

The treatment was generally well-tolerated, although common side effects included myelosuppression and hand-foot syndrome, with 84.4% of patients experiencing neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Docetaxel and capecitabine combination chemotherapy for patients with anthracycline-resistant metastatic breast cancer]. Li, SF., Wang, X., Wang, C., et al.[2018]

Capecitabine, when used as a monotherapy for advanced breast cancer, showed some antitumor activity but had a significant risk of side effects like hand-foot syndrome and diarrhea, and the evidence supporting its effectiveness is limited due to low-quality studies.

In combination with docetaxel, capecitabine demonstrated superior survival and disease progression outcomes compared to docetaxel alone, and while it appeared to be cost-effective, it was associated with higher rates of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the clinical effectiveness and cost-effectiveness of capecitabine (Xeloda) for locally advanced and/or metastatic breast cancer. Jones, L., Hawkins, N., Westwood, M., et al.[2023]

In a study of 63 patients with relapsed and refractory multiple myeloma, the pomalidomide-dexamethasone regimen showed a 51% overall response rate, with significant survival benefits for responders compared to those who discontinued treatment early.

The regimen was found to have a favorable safety profile, with the most common severe side effects being neutropenia (14%) and infections (25%), and it was cost-effective, providing a life-year gain at an incremental cost of €39,911 compared to dexamethasone alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and cost of pomalidomide in relapsed and refractory multiple myeloma. Gueneau, P., Chretien, ML., Cransac-Miet, A., et al.[2018]

Capecitabine, an oral prodrug of 5-fluorouracil, has shown promising efficacy in treating advanced breast cancer, with a response rate of 20% in a phase II study involving 135 patients previously treated with anthracyclines and taxanes.

The side effects of capecitabine are generally mild, with the most common severe toxicities being diarrhea (8%-11%) and hand-foot syndrome (10%-18%), indicating it has a tolerable safety profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine in breast cancer: current status. Smorenburg, CH., Bontenbal, M., Verweij, J.[2015]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3000

DB-1310, a HER3-targeted ADC, in pts with advanced ... DB-1310 showed a manageable safety profile and encouraging antitumor activity in pts with heavily pretreated advanced solid tumors, particularly EGFRm NSCLC.

2. uclahealth.org uclahealth.org/news/release/asco-her3-targeted-antibody-drug-conjugate-adc-shows-promise

ASCO: HER3-targeted antibody-drug conjugate (ADC) ... A new targeted cancer drug, DB-1310, is showing early signs of effectiveness in patients with advanced solid tumors that have not responded to standard ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05785741

A Study of DB-1310 in Advanced/Metastatic Solid Tumors This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.

4. cancernetwork.com cancernetwork.com/view/db-1310-earns-fda-fast-track-designation-in-egfr-mutant-nonsquamous-nsclc

DB-1310 Earns FDA Fast Track Designation in EGFR ... The median PFS and OS were 7.03 months (95% CI, 4.14-8.41) and 18.89 months (95% CI, 11.63-NE), respectively. Notably, among patients treated at ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11022355/

DB-1310, an ADC comprised of a novel anti-HER3 ... DB-1310 exerted potent antitumor activities against HER3 + tumors in in vitro and in vivo models, and showed acceptable safety profiles in nonclinical species.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05785741

A Study of DB-1310 in Advanced/Metastatic Solid Tumors A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...

7. cancerbiomed.org cancerbiomed.org/content/early/2025/03/19/j.issn.2095-3941.2024.0586.1

DB-1310, a HER3-targeting antibody-drug conjugate, has ... DB-1310 combined with trastuzumab synergistically inhibit the proliferation of BC cells with high HER2 and HER3 expression.

8. onclive.com onclive.com/view/fda-grants-fast-track-designation-to-next-generation-her3-directed-adc-for-egfr-advanced-nsclcancer

FDA Grants Fast Track Designation to Next-Generation ... DB-1310 received FDA fast track designation for advanced nonsquamous NSCLC with specific EGFR mutations, showing potential as a novel ...