A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

Phase 2 trial of Zanidatamab for HER2-positive solid tumors recruiting

NCT: NCT06695845 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Jazz Pharmaceuticals · Started: 2025-01-14 · Est. Completion: 2027-12-31

Plain English Summary

A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors is a Phase 2 clinical trial sponsored by Jazz Pharmaceuticals studying Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer, Colorectal Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Urothelial Carcinoma, Salivary Gland Cancer. This study tests Zanidatamab, an investigational drug, in adults with previously treated solid tumors that have a specific marker called HER2. It is for patients with certain types of cancer, including breast, gastric, esophageal, and others, who have not responded to previous treatments. Participation involves receiving Zanidatamab intravenously, with regular check-ups and tests to monitor its effects and safety. Alternative treatments may include other targeted therapies, chemotherapy, or participation in other clinical trials, depending on the specific cancer and prior treatments. The trial aims to enroll 200 participants.

Official Summary

The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced or metastatic solid tumors that express HER2 (IHC 3+). Patients must have progressed on at least one prior treatment for advanced disease and have no other effective treatment options. Individuals with stable, treated brain metastases may be eligible if they meet specific criteria. Patients with certain genetic mutations in colorectal or non-small cell lung cancer, or those with known leptomeningeal disease or untreated brain metastases, are not eligible. This trial is studying Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer, Colorectal Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Urothelial Carcinoma, Salivary Gland Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well Zanidatamab shrinks tumors, indicating its effectiveness in treating these specific cancers. The specific primary outcome measures are: Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR (Up to 2.5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a significant unmet need for patients with HER2-expressing solid tumors who have exhausted standard treatment options, offering a potential new therapeutic avenue. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer, Colorectal Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Urothelial Carcinoma, Salivary Gland Cancer, where improved treatment options are needed.

Investor Insight

This trial signals potential for Zanidatamab in a broad range of HER2-expressing solid tumors, a market with significant unmet needs, suggesting a potentially high probability of success if efficacy i Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if your tumor is HER2-expressing (IHC 3+) and if this trial is a suitable option for you. Be prepared for regular clinic visits for infusions and monitoring, which may include blood tests, scans, and assessments of your general health. Understand that this is an open-label study, meaning both you and your doctor will know you are receiving Zanidatamab. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

1. Is at least 18 years of age inclusive at the time of signing the informed consent
2. Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.
3. HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.
4. All participants must have adequate tumor sample for submission to allow central HER2 testing.
5. Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Has a life expectancy of at least 3 months, in the opinion of the investigator.
8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:

   1. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.
   2. Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to \< Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment \> 7 days prior to Cycle 1 Day 1.
   3. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.
9. Adequate organ functions.
10. Females of childbearing potential must have a negative pregnancy test result.
11. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Exclusion Criteria:

1. Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
2. Has uncontrolled or significant cardiovascular disease
3. Has ongoing toxicity related to prior cancer therapy
4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
5. Has known Human Immunodeficiency Virus (HIV) infection.
6. Has active hepatitis B or C infection.
7. Has an active SARS-CoV-2 infection.
8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.
9. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.
10. Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study.
11. Prior treatment with HER2-targeted therapy (Cohort 1 only).
12. Has a history of trauma or major surgery
13. Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
14. Received zanidatamab at any time prior to the current study.
15. Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.
16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.
17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
18. Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06695845?

NCT06695845 is a Phase 2 INTERVENTIONAL study titled "A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors." It is currently recruiting and is sponsored by Jazz Pharmaceuticals. The trial targets enrollment of 200 participants.

What conditions does NCT06695845 study?

This trial investigates treatments for Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer, Colorectal Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Urothelial Carcinoma, Salivary Gland Cancer. The primary condition under study is Breast Cancer.

What treatments are being tested in NCT06695845?

The interventions being studied include: Zanidatamab (DRUG). Administered by intravenous (IV) infusion

What does Phase 2 mean for NCT06695845?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT06695845?

This trial is currently "Recruiting." It started on 2025-01-14. The estimated completion date is 2027-12-31.

Who is sponsoring NCT06695845?

NCT06695845 is sponsored by Jazz Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06695845?

The trial aims to enroll 200 participants. The trial is currently recruiting and accepting new participants.

How is NCT06695845 designed?

This is a interventional study, uses non_randomized allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT06695845?

The primary outcome measures are: Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR (Up to 2.5 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06695845 being conducted?

This trial is being conducted at 20 sites, including Prescott, Arizona; Littleton, Colorado; Fort Myers, Florida; Orlando, Florida and 16 more sites (United States, South Korea).

Where can I find official information about NCT06695845?

The official record for NCT06695845 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06695845. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06695845 testing in simple terms?

This study tests Zanidatamab, an investigational drug, in adults with previously treated solid tumors that have a specific marker called HER2. It is for patients with certain types of cancer, including breast, gastric, esophageal, and others, who have not responded to previous treatments.

Why is this trial significant?

This trial addresses a significant unmet need for patients with HER2-expressing solid tumors who have exhausted standard treatment options, offering a potential new therapeutic avenue.

What are the potential risks of participating in NCT06695845?

Common side effects may include diarrhea, nausea, vomiting, fatigue, and infusion-related reactions. Serious side effects can occur, including severe allergic reactions and heart problems, which will be closely monitored. The study requires adequate tumor samples for testing, which may involve a biopsy if a suitable sample is not available. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06695845?

Ask your doctor if your tumor is HER2-expressing (IHC 3+) and if this trial is a suitable option for you. Be prepared for regular clinic visits for infusions and monitoring, which may include blood tests, scans, and assessments of your general health. Understand that this is an open-label study, meaning both you and your doctor will know you are receiving Zanidatamab. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06695845 signal from an investment perspective?

This trial signals potential for Zanidatamab in a broad range of HER2-expressing solid tumors, a market with significant unmet needs, suggesting a potentially high probability of success if efficacy i This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participation involves receiving Zanidatamab intravenously, with regular check-ups and tests to monitor its effects and safety. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.