ADRX-0706 for Cancer

Recruiting at 22 trial locations

Overseen By Adcentrx Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Adcentrx Therapeutics

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

Disqualifiers: CNS metastases, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ADRX-0706 to assess its safety and tolerability in individuals with certain advanced solid tumors. The goal is to determine the optimal dose for further studies. The trial consists of two parts: the first gradually increases doses to identify the maximum safe amount, and the second tests a recommended dose in specific cancer types, such as urothelial cancer, triple-negative breast cancer, and cervical cancer. Individuals with these cancers who have tried at least one previous treatment and have no other effective options may be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment 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 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.

Is there any evidence suggesting that ADRX-0706 is likely to be safe for humans?

Research has shown that ADRX-0706 appears safe in early lab tests. These tests, conducted before human trials, indicated that the drug was well-tolerated. Additionally, ADRX-0706 received fast-track status from the FDA for advanced cervical cancer. This status is often granted to treatments that may meet important medical needs, suggesting the drug's potential safety.

As this study begins with human participants, more detailed safety information will emerge as more individuals join. However, the early results are promising. Updates will follow as the study continues to confirm these initial findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Unlike the standard cancer treatments like chemotherapy, radiation, or surgery, ADRX-0706 offers a novel approach by targeting specific pathways involved in cancer cell growth. This treatment is designed to precisely hit cancer cells while sparing healthy ones, potentially reducing side effects common with current therapies. Researchers are particularly excited about ADRX-0706 because it could provide a more personalized and effective treatment option for patients with urothelial cancer, triple negative breast cancer, and cervical cancer.

What evidence suggests that ADRX-0706 might be an effective treatment for cancer?

Research shows that ADRX-0706 may help treat certain advanced solid tumors. Early results found that it reduced tumor size by 27% and 29% in patients with triple negative breast cancer (TNBC) who continued the treatment. ADRX-0706 targets a protein called Nectin-4, which plays a role in tumor growth, and this targeting is believed to help shrink tumors. The FDA has fast-tracked the treatment for advanced cervical cancer, indicating its potential effectiveness. These findings suggest ADRX-0706 could be a promising option for conditions like TNBC and cervical cancer.

In this trial, ADRX-0706 will be administered in two phases. Phase 1a will focus on dose escalation to identify the maximum tolerated dose. Phase 1b will expand to disease-specific cohorts, including urothelial cancer, TNBC, and cervical cancer, using the recommended dose from Phase 1a. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ADRX-0706

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06036121

A Study of ADRX-0706 in Select Advanced Solid Tumors 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 ...

2. adcentrx.com adcentrx.com/adcentrx-asco-2025-presentations/

Adcentrx Therapeutics to Present First Clinical Data for ... ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3018

Preliminary results from a first-in-human phase 1 dose ... ... triple negative BC (TNBC) subjects with 27% and 29% decrease in tumor size who remain on treatment. ADRX-0706 demonstrated Nectin-4 ...

4. onclive.com onclive.com/view/adrx-0706-secures-fda-fast-track-designation-for-advanced-squamous-cell-cervical-cancer

ADRX-0706 Secures FDA Fast Track Designation for ... ADRX-0706, targeting nectin-4, received FDA fast track designation for advanced cervical cancer, highlighting its potential in addressing unmet ...

5. bcan.org bcan.org/clinicaltrials/adrx-0706-in-select-advanced-solid-tumors/

ADRX-0706 in Select Advanced Solid Tumors The Phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of ADRX-0706 in patients with ...

6. adcentrx.com adcentrx.com/adcentrx-therapeutics-granted-fast-track-designation-adrx-0706/

Adcentrx Therapeutics Granted Fast Track Designation for ... ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a ...