What side effects are associated with this type of intervention?

Common treatments for advanced solid tumors, such as chemotherapy, targeted therapy, and immunotherapy, often come with a range of side effects. Chemotherapy can cause hematologic toxicities like neutropenia, anemia, and thrombocytopenia, as well as non-hematologic effects such as nausea, fatigue, and neuropathy. Targeted therapies may lead to specific side effects depending on the target, including hypertension, diarrhea, and skin rashes. Immunotherapy, particularly immune checkpoint inhibitors, can result in immune-related adverse events like colitis, pneumonitis, and thyroid dysfunction. These side effects vary in severity and frequency, and managing them is crucial for patient care.

What prior FDA approvals exist?

Several therapeutic agents have been approved by the FDA for the treatment of advanced solid tumors. These include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1/PD-L1 pathways, and have shown efficacy in various solid tumors such as melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, targeted therapies like osimertinib for EGFR-mutated non-small cell lung cancer and trastuzumab for HER2-positive breast cancer have been approved. These treatments focus on specific molecular targets and have demonstrated significant improvements in patient outcomes. The investigational agent ADRX-0706, being studied for its safety, tolerability, and optimal dosing in advanced solid tumors, is likely aiming to join this class of targeted and immune-based therapies.

What other types of research exist?

Promising novel alternatives to ADRX-0706 for solid tumor patients in 2024 include: 1) Cabozantinib, which has shown efficacy in advanced Ewing sarcoma and osteosarcoma; 2) Regorafenib, which has demonstrated benefits in metastatic osteosarcoma; 3) Niraparib plus nivolumab or niraparib plus ipilimumab, which are being investigated for platinum-sensitive advanced pancreatic cancer; 4) Futibatinib, an FGFR-selective tyrosine kinase inhibitor for cholangiocarcinoma with FGFR2 fusions/rearrangements; and 5) T-DXd (fam-trastuzumab deruxtecan), which has shown promise in HER2-positive metastatic breast cancer.

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ADRX-0706 for Cancer

Phase 1

Recruiting

Research Sponsored by Adcentrx Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including urothelial carcinoma (UC), head and neck squamous cell carcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Active and uncontrolled central nervous system metastases

Significant cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until study completion (estimated 3 years)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects in trials like this may include fatigue, nausea, diarrhea, decreased appetite and potential risks related to liver or kidney function due to the nature of anticancer drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a serious heart condition.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until study completion (estimated 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until study completion (estimated 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until study completion (estimated 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence of anti-drug antibodies (ADA)

Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706

Measurement of disease control rate (DCR)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 1b Dose ExpansionExperimental Treatment1 Intervention

ADRX-0706 will be initially administered at the dose recommended from the Phase 1a part in 3 disease-specific cohorts.

Group II: Phase 1a Dose EscalationExperimental Treatment1 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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as those inhibiting specific proteins or pathways (e.g., HER2, VEGF), aim to block the growth and spread of cancer cells with fewer side effects. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells, often by targeting immune checkpoints like PD-1/PD-L1. These mechanisms are crucial for patients with advanced solid tumors as they offer different strategies to control tumor growth, improve survival, and maintain quality of life. ADRX-0706, likely a novel agent, may offer a new mechanism or an improved approach within these categories, potentially providing better outcomes for patients with advanced solid tumors.