ADRX-0706 for Cancer

Recruiting at20 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Adcentrx Therapeutics

Must not be taking: P-gp inducers, CYP3A inhibitors

Disqualifiers: CNS metastases, Cardiovascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called ADRX-0706 in patients with advanced cancers. It aims to find out if the drug is safe, what side effects it might have, and the best dose to use.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anticancer or investigational therapy within 5 elimination half-lives or 14 days before starting the study drug. Additionally, you must not take any P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose.

How does the drug ADRX-0706 differ from other cancer treatments?

ADRX-0706 may offer a unique approach compared to standard treatments by potentially utilizing a novel mechanism of action or administration route, similar to how intraperitoneal (ip) administration of adriamycin (ADR) showed improved effectiveness and reduced toxicity in murine models of ovarian cancer. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for people with certain advanced solid tumors who have tried at least one treatment but don't have other options that could help. They should be relatively healthy and active (ECOG status 0 or 1) and have measurable disease. Cancers included are urothelial, head & neck, breast, cervical, ovarian, lung (NSCLC), and pancreatic cancer.

Inclusion Criteria

You have a detectable illness according to the RECIST version 1.1 guidelines.

I have advanced cancer, such as breast, lung, or ovarian cancer.

I've had at least one treatment for my condition and there are no other known beneficial treatments available.

Exclusion Criteria

My cancer has spread to my brain and is not under control.

I have a serious heart condition.

I have not had any other cancer besides the one I'm being treated for in the last 3 years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Dose Escalation

Increasing doses of ADRX-0706 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose for Phase 1b

Estimated 6-12 months

Phase 1b Dose Expansion

ADRX-0706 will be administered at the recommended dose from Phase 1a in 3 disease-specific cohorts: urothelial cancer, triple negative breast cancer, and cervical cancer

Estimated 12-18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Estimated 3 years

Treatment Details

Interventions

• ADRX-0706 (Other)

Trial Overview ADRX-0706 is being tested to find the safest dose that can be tolerated by patients with specific advanced solid tumors. The study will also look at how the body processes this drug.

Participant Groups

Group I: Phase 1b Dose Expansion Experimental Treatment 1 Intervention

ADRX-0706 will be initially administered to patients at the dose recommended from the Phase 1a part in 3 disease-specific cohorts: urothelial cancer, triple negative breast cancer, and cervical cancer.

Group II: Phase 1a Dose Escalation Experimental Treatment 1 Intervention

Increasing doses of ADRX-0706 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part.

Who Is Running the Clinical Trial?

Adcentrx Therapeutics

Lead Sponsor

Trials

2

Recruited

210+

Findings from Research

The combination of adriamycin (ADM) and cisplatin (DDP) did not enhance the effectiveness of DDP alone in treating murine reticulum cell sarcoma, indicating that ADM may not provide additional benefits in this context.

Repeated cycles of DDP significantly increased the lifespan of the mice, with a regimen administered at fixed intervals showing better local tumor control compared to a regimen based on tumor regrowth, although the latter was better tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schedule-dependent effectiveness of ADM and multiple cycles of DDP on a murine reticulum sarcoma. Leonetti, C., Zupi, G., Calabresi, F., et al.[2013]

Phase III randomized clinical trials are essential for understanding cancer treatment, but they rely heavily on earlier Phase I and II studies to identify effective therapies, as seen in the successful treatment of acute lymphocytic leukemia.

Adjuvant chemotherapy has significantly reduced mortality rates in breast and colon cancers, while neoadjuvant chemotherapy improves surgical options and quality of life, even if it doesn't always increase survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trials and other approaches in clinical research. Frei, E.[2019]

Intraperitoneal (ip) administration of Adriamycin (ADR) significantly improves survival in mice with murine ovarian cancer, with 70% of treated mice surviving longer than 60 days, compared to no survival benefit from intravenous (iv) administration.

The enhanced efficacy of ip ADR is attributed to better tumor penetration, greater suppression of DNA synthesis, and lower cardiotoxicity compared to iv administration, suggesting ip ADR could be a promising treatment for patients with intra-abdominal tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy for murine ovarian cancer: a rationale for ip therapy with adriamycin. Ozols, RF., Locker, GY., Doroshow, JH., et al.[2013]

The hybrid administration of vinorelbine (VNR) and cisplatin (CDDP) as a first-line treatment for advanced non-small cell lung cancer (aNSCLC) was found to be feasible and effective, with a median overall survival of 10 months among 53 patients studied.

While the treatment caused some significant side effects, such as grade 3-4 neutropenia in 23-24% of patients, non-hematological toxicities were rare, indicating a manageable safety profile for this regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid (intravenous and oral) administration of vinorelbine plus cisplatinum followed by oral vinorelbine as first-line therapy of advanced non-small cell lung cancer: a phase II study. Martoni, AA., Melotti, B., Sperandi, F., et al.[2018]

The combination of vinorelbine (VRL) and hydrocortisone significantly improved progression-free survival (PFS) and prostate-specific antigen (PSA) response rates in patients with hormone-refractory prostate cancer compared to hydrocortisone alone, with 6-month PFS rates of 33.2% versus 22.8%.

VRL plus hydrocortisone was well tolerated among elderly patients, showing a low incidence of severe side effects, making it a safe treatment option despite not improving overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised phase III study of intravenous vinorelbine plus hormone therapy versus hormone therapy alone in hormone-refractory prostate cancer. Abratt, RP., Brune, D., Dimopoulos, MA., et al.[2020]

References

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

Schedule-dependent effectiveness of ADM and multiple cycles of DDP on a murine reticulum sarcoma. [2013]

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

Randomized clinical trials and other approaches in clinical research. [2019]

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

Chemotherapy for murine ovarian cancer: a rationale for ip therapy with adriamycin. [2013]

4. Ireland pubmed.ncbi.nlm.nih.gov

Hybrid (intravenous and oral) administration of vinorelbine plus cisplatinum followed by oral vinorelbine as first-line therapy of advanced non-small cell lung cancer: a phase II study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Randomised phase III study of intravenous vinorelbine plus hormone therapy versus hormone therapy alone in hormone-refractory prostate cancer. [2020]