A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic Solid Tumors

Plain English Summary

A Study of DB-1310 in Advanced/Metastatic Solid Tumors is a Phase 2 clinical trial sponsored by DualityBio Inc. studying Advanced Solid Tumor. This trial tests a new drug called DB-1310, alone or with other cancer treatments, to see if it's safe and effective for advanced cancers. It is for adults with advanced or metastatic solid tumors that have not responded to or cannot tolerate standard treatments. Participants will receive DB-1310, possibly combined with other drugs, and will have regular medical check-ups and tests. Alternative treatments may include chemotherapy, targeted therapy, or immunotherapy, depending on the specific cancer type. The trial aims to enroll 1000 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced solid tumors that have spread or cannot be removed by surgery. Patients whose cancer has progressed after standard treatments, or for whom no standard treatment is available. Individuals with at least one measurable tumor and a life expectancy of at least 3 months, and good general health (ECOG 0-1). Patients must not have received prior treatment with HER3-targeted therapy and must have adequate heart function. This trial is studying Advanced Solid Tumor, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the drug is by looking at side effects and determining the highest dose that can be given without causing unacceptable harm, which helps establish a safe dose for The specific primary outcome measures are: Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs (up to 21 days after Cycle 1 Day 1); Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0. (Up to follow-up period, approximately 1 year post-treatment); Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. (Up to follow-up period, approximately 1 year post-treatment); Maximum Tolerated Dose (MTD) of DB-1310 (12 months); Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1310 (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial is important because it explores a new treatment option for patients with advanced solid tumors who have limited or no other treatment choices, addressing a significant unmet need in cancer Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Advanced Solid Tumor, where improved treatment options are needed.

Investor Insight

This trial represents an early-stage investment in a novel targeted therapy for a broad range of solid tumors, with potential for significant market impact if proven effective, though early-phase tria Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval. The large enrollment target of 1000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific type of cancer being studied, the potential benefits and risks of DB-1310, and how it might affect your quality of life. Be prepared for regular visits for drug infusions, blood tests, scans to check tumor size, and monitoring for side effects. Understand that you may need to provide tumor tissue samples for biomarker testing to help researchers understand how the drug works. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 1,000 participants

Interventions

• DRUG: DB-1310 — Administered I.V.
• DRUG: Trastuzumab — Administered I.V.
• DRUG: Osimertinib — Oral
• DRUG: capecitabine — Oral

Primary Outcomes

• Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs (up to 21 days after Cycle 1 Day 1)
• Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0. (Up to follow-up period, approximately 1 year post-treatment)
• Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. (Up to follow-up period, approximately 1 year post-treatment)
• Maximum Tolerated Dose (MTD) of DB-1310 (12 months)
• Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1310 (12 months)

Secondary Outcomes

• Phase 1 & Phase 2a: Pharmacokinetic-AUC (within 8 cycles (each cycle is 21 days))
• Phase 1 & Phase 2a: Pharmacokinetic-Cmax (within 8 cycles (each cycle is 21 days))
• Phase 1 & Phase 2a: Pharmacokinetic-Tmax (within 8 cycles (each cycle is 21 days))
• Phase 1 & Phase 2a: Pharmacokinetic-T1/2 (within 8 cycles (each cycle is 21 days))
• Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1 (with 8 cycles (each cycle is 21 days))

Full Eligibility Criteria

Inclusion Criteria

1. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
2. Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.
3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
4. Has a life expectancy of ≥ 3 months.
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
7. Is willing to provide archived tumor tissue or undergo fresh tumor biopsy for the retrospective measurement of human epidermal growth factor receptor 3 (HER3) level and other biomarkers if no contraindication. For HER2 IHC 0 breast cancer subjects, it is highly recommended to collect additional tumor sample (Refer to Lab Manual).
8. Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.
9. Male and female subjects of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months after the last dose of study drug, respectively.

   Females must be using highly effective contraceptive measures during the study and for at least 7 months after the last dosing of study drug, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
   * Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
   * Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
   * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
10. Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration.
11. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
12. Phase 1 monotherapy subjects (Phase 1 monotherapy ONLY):

    * Pathologically documented advanced/unresectable, or metastatic solid tumors that is refractory to or intolerable with standard treatment, or for which standard treatment is not available.

Exclusion Criteria

1. Prior treatment with HER3 targeted therapy.
2. Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1).
3. Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment.
4. Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \> 250 milliseconds (ms).
6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.
7. Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval.

   For Combo B of Phase 1 and Cohort 2g, 2k of Phase 2a, patients currently receiving (or unable to stop use prior to receiving the first dose of Osimertinib) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3-week prior) (refer to Section 6.9.1) are ineligible, and all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with

Trial Locations

• University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States
• UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
• Research Site 117, Coral Gables, Florida, United States
• D&H Cancer Research Center LLC, Margate, Florida, United States
• Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States
• BRCR global, Plantation, Florida, United States
• Florida Cancer Specialists, Sarasota, Florida, United States
• BRCR Medical Center Inc., Tamarac, Florida, United States
• Research Site 111, Atlanta, Georgia, United States
• Dana-Farber Cancer Institute, Boston, Massachusetts, United States
• ...and 10 more locations

Frequently Asked Questions

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• Breast Cancer
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