DAY301 for Cancer

Recruiting at 3 trial locations

Overseen By Day One Clinical Trials Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Day One Biopharmaceuticals, Inc.

Must not be taking: PTK7 targeting treatment

Disqualifiers: Brain metastases, Leptomeningeal disease, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and anti-tumor activity of DAY301, a PTK7-directed antibody-drug conjugate in patients with advanced or metastatic solid tumors. The study comprises of 2 phases: Phase 1a dose escalation where patients will be administered DAY301 at escalating dose levels to assess safety and tolerability, and to determine the maximum tolerated dose (MTD) and/or the recommended dose (RD); In Phase 1b dose expansion, DAY301 will be evaluated in dose expansion cohorts.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic cancer treatments at least 4 weeks or 5 half-lives (whichever is shorter) before starting the study drug. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What safety data exists for molecular target anticancer drugs like DAY301?

Molecular target anticancer drugs, which may include treatments like DAY301, have been shown to increase the risk of serious and fatal adverse events compared to placebo. It's important for patients to be aware of these risks and for healthcare providers to monitor for these potential side effects. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for people with advanced or metastatic solid tumors. Participants must be adults who can tolerate treatment and have measurable disease as per specific criteria. Key exclusions include prior adverse reactions to similar drugs, certain heart conditions, uncontrolled illnesses, brain metastases not stable or requiring steroids, and pregnancy.

Inclusion Criteria

I can provide a sample of my tumor tissue.

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

I am fully active or can carry out light work.

Exclusion Criteria

My cancer has spread to my brain or its coverings.

I haven't taken cancer drugs or participated in other cancer studies within the last 4 weeks.

I have previously been treated with PTK7 targeting therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Participants receive DAY301 at escalating dose levels to assess safety and tolerability, and to determine the maximum tolerated dose (MTD) and/or the recommended dose (RD)

21 days for DLT observation, up to 12 months total

Multiple visits for dose administration and monitoring

Phase 1b: Dose Expansion

DAY301 is evaluated in dose expansion cohorts to further assess safety and antitumor activity

up to 12 months

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• DAY301

Trial Overview The study tests DAY301, a new drug targeting PTK7 in cancer cells. It's an early-phase trial with two parts: first finding the highest safe dose (Phase 1a), then seeing how well it works at that dose in more patients (Phase 1b).

Participant Groups

Group I: DAY301 intravenous (IV) infusion Experimental Treatment 1 Intervention

DAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts.

Who Is Running the Clinical Trial?

Day One Biopharmaceuticals, Inc.

Lead Sponsor

Trials

8

Recruited

1,100+

Findings from Research

A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.

The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. Wang, Z., Yang, X., Wang, J., et al.[2020]

A follow-up program involving pharmacists for outpatients treated with oral antineoplastic agents (OAA) showed a reduction in severe adverse events (AEs) and major drug interactions compared to patients who were not monitored, indicating improved safety in the intervention group.

The study included 249 patients over a 6-month period, revealing that while AEs were still common, the intervention group experienced fewer severe AEs and had better monitoring of drug interactions, particularly with medications like erlotinib and gefitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents. Escudero-Vilaplana, V., Ribed, A., Romero-Jimenez, RM., et al.[2018]

All-case post-marketing surveillance in Japan identified 58 fatal adverse drug reactions that were not previously reported on drug labels, highlighting its role in uncovering safety issues after drug approval.

Despite detecting a significant number of fatal adverse reactions, regulatory actions were limited, with only four warning letters issued, indicating a gap in response to the findings from post-marketing surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan. Mori, J., Tanimoto, T., Miura, Y., et al.[2018]

A review of all-case surveillance studies (ACSS) for oncology drugs in Japan from 2006 to 2015 revealed that most revisions to drug package inserts regarding serious adverse events were primarily based on spontaneous reports from clinicians rather than ACSS data.

The findings suggest that ACSS may not significantly contribute to updating package inserts, indicating a need for a more efficient system for reporting adverse events that could reduce the burden on the pharmaceutical industry and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Industry-Conducted All-Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan? Suzuki, A., Sato, H., Sasaki, Y.[2020]

In a study of 132 patients with advanced gastric cancer, the alternate-day administration of S-1 chemotherapy resulted in a significantly lower progression-free survival (PFS) rate of 20.9% compared to 39.1% for daily administration, indicating that the alternate schedule is less effective.

The alternate-day regimen also showed a shorter median time to treatment failure (TTF) of 2.8 months versus 4.2 months for daily treatment, leading to the conclusion that alternate-day S-1 is not recommended as a first-line therapy due to its inferior efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized phase II study of daily and alternate-day administration of S-1 for advanced gastric cancer (JFMC43-1003). Tanaka, H., Kanda, M., Morita, S., et al.[2018]

References

1. India pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Does Industry-Conducted All-Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan? [2020]

5. Japan pubmed.ncbi.nlm.nih.gov

Randomized phase II study of daily and alternate-day administration of S-1 for advanced gastric cancer (JFMC43-1003). [2018]