DAY301 for Cancer

Recruiting at 12 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

254 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DAY301, designed to target and fight cancer cells in various advanced or metastatic solid tumors, such as ovarian and lung cancer. The main goal is to determine the safety of DAY301 for patients and its effectiveness against tumors. Participants will receive different doses of DAY301 to identify the optimal balance between effectiveness and safety. This trial may suit individuals with solid tumor cancers, like triple-negative breast cancer or esophageal cancer, who have not found success with standard treatments. As a Phase 1 trial, this research focuses on understanding how DAY301 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that DAY301 is likely to be safe for humans?

Research shows that DAY301 is a new treatment undergoing testing to determine its safety for people. As an early-stage trial (Phase 1), the primary goal is to assess how well participants tolerate the treatment and to establish the correct dose. DAY301 targets specific proteins on cancer cells, delivering medicine directly to them.

Currently, limited information exists about DAY301's safety in humans. This testing phase identifies any side effects and observes how different doses affect participants' bodies. Early trials of similar cancer treatments have shown a risk of serious side effects, so researchers proceed with caution. However, the exact effects of DAY301 remain under investigation. Participants in this trial will contribute to understanding its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about DAY301 for cancer treatment because it offers a new approach through its unique mechanism of action. Unlike many existing cancer treatments that target the cancer cells directly, DAY301 works by modulating the tumor's environment to make it less hospitable for cancer growth. This intravenous infusion could potentially enhance efficacy and reduce side effects by focusing on the tumor's support systems rather than attacking the cancer cells themselves. This innovative approach might provide more effective and gentler treatment options for patients compared to current standards like chemotherapy and radiation.

What evidence suggests that DAY301 might be an effective treatment for cancer?

Research has shown that DAY301, a new cancer treatment, has produced promising results in animal studies. It targets specific proteins on cancer cells, enhancing their destruction. Early findings suggest that DAY301 can reduce tumor size in various solid tumors. These studies serve as preliminary tests to predict a treatment's effectiveness in humans. While DAY301 is still undergoing testing in this trial through intravenous (IV) infusion, these initial results are encouraging for its potential to treat advanced or spreading solid tumors. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06752681

Study Details | NCT06752681 | To Evaluate the Safety, ... This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and anti-tumor activity of DAY301, ...

2. dayonebio.com dayonebio.com/wp-content/uploads/2025/04/Sommerhalder-AACR-2025-DAY301-TIP-Poster_04.15.2025.pdf

A phase 1, open label, multiple dose, dose escalation, and ... • DAY301 is being administered by intravenous injection once every 3 weeks. • Patients may be enrolled in backfill cohorts to further ...

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/DAWN-Q/pressreleases/35744148/day-one-biopharmaceuticals-advances-cancer-treatment-with-day301-study/

Day One Biopharmaceuticals Advances Cancer Treatment ... ' The study aims to evaluate the safety and anti-tumor activity of DAY301, a PTK7-directed antibody-drug conjugate, in patients with advanced or ...

4. finance.yahoo.com finance.yahoo.com/news/day-one-announces-ojemda-tovorafenib-120000603.html

Day One Announces New OJEMDA™ (tovorafenib) Data to ... Three-year follow-up data from FIREFLY-1 demonstrates durable responses with evidence of clinical stability off treatment, ...

5. researchgate.net researchgate.net/publication/391189121_Abstract_CT196_Phase_1_dose_escalation_and_expansion_study_of_the_PTK7-targeted_antibody-drug_conjugate_DAY301_in_patients_with_locally_advanced_or_metastatic_solid_tumors

Abstract CT196: Phase 1 dose escalation and expansion ... The drug-to-antibody ratio is 8. DAY301 has demonstrated potent antitumor activity in wide range of tumor xenograft models in vivo, with ...

6. ir.dayonebio.com ir.dayonebio.com/news-releases/news-release-details/day-one-announces-new-ojemdatm-tovorafenib-data-be-presented

Day One Announces New OJEMDA™ (tovorafenib) Data to be ... Three-year follow-up data from FIREFLY-1 demonstrates durable responses with evidence of clinical stability off treatment, ...

7. ctv.veeva.com ctv.veeva.com/study/to-evaluate-the-safety-tolerability-pharmacokinetics-and-antitumor-activity-of-day301-in-participa

To Evaluate the Safety, Tolerability, Pharmacokinetics and ... This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and anti-tumor activity of DAY301, ...

8. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT196/761385/Abstract-CT196-Phase-1-dose-escalation-and

Phase 1 dose escalation and expansion study of the PTK7 ... The drug-to-antibody ratio is 8. DAY301 has demonstrated potent antitumor activity in wide range of tumor xenograft models in vivo, with ...

9. withpower.com withpower.com/trial/phase-1-neoplasms-10-2024-3d2da

DAY301 for Cancer · Recruiting Participants for Phase ... Molecular target anticancer drugs, which may include treatments like DAY301, have been shown to increase the risk of serious and fatal adverse events compared ...