CLINICAL TRIALS PROFILE FOR ZALTRAP

All Clinical Trials for ZALTRAP

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00284141 ↗	Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma	Completed	Regeneron Pharmaceuticals	Phase 2	2006-01-01	This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA). Primary objective: - To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA. Secondary objective: - To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this participant population - To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®). This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.
NCT00284141 ↗	Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma	Completed	Sanofi	Phase 2	2006-01-01	This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA). Primary objective: - To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA. Secondary objective: - To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this participant population - To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®). This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.
NCT00327171 ↗	Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer	Completed	Regeneron Pharmaceuticals	Phase 2	2006-05-01	This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept. The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks with historical control in participants with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin. The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life. This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the IRC reviewed data is reported for this study.
NCT00327171 ↗	Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer	Completed	Sanofi	Phase 2	2006-05-01	This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept. The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks with historical control in participants with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin. The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life. This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the IRC reviewed data is reported for this study.
NCT00327444 ↗	Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites	Completed	Regeneron Pharmaceuticals	Phase 2/Phase 3	2006-07-01	This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer. Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.

Clinical Trial Conditions for ZALTRAP

Condition Name

Condition Name for ZALTRAP
Intervention	Trials
Recurrent Rectal Cancer	3
Metastatic Colorectal Cancer	3
Recurrent Colon Cancer	3
Colorectal Cancer Metastatic	2

Condition MeSH

Condition MeSH for ZALTRAP
Intervention	Trials
Colorectal Neoplasms	13
Ovarian Neoplasms	6
Rectal Neoplasms	6
Neoplasms	4

Clinical Trial Locations for ZALTRAP

Trials by Country

Trials by Country for ZALTRAP
Location	Trials
United States	66
Canada	7
Greece	4
Italy	3
Spain	3

Trials by US State

Trials by US State for ZALTRAP
Location	Trials
California	6
Virginia	4
Texas	4
New Jersey	4
Maryland	3

Clinical Trial Progress for ZALTRAP

Clinical Trial Phase

Clinical Trial Phase for ZALTRAP
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	2
Phase 2	19

Clinical Trial Status

Clinical Trial Status for ZALTRAP
Clinical Trial Phase	Trials
Completed	18
Withdrawn	5
Recruiting	5

Clinical Trial Sponsors for ZALTRAP

Sponsor Name

Sponsor Name for ZALTRAP
Sponsor	Trials
Sanofi	11
National Cancer Institute (NCI)	9
Regeneron Pharmaceuticals	7

Sponsor Type

Sponsor Type for ZALTRAP
Sponsor	Trials
Other	22
Industry	21
NIH	9

ZALTRAP: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 21, 2026

What Are the Latest Clinical Trial Developments for ZALTRAP?

ZALTRAP (conatumumab), a monoclonal antibody targeting the ERBB3 receptor, has undergone multiple clinical trials assessing its efficacy in various cancers, primarily metastatic colorectal cancer and non-small cell lung cancer (NSCLC).

Ongoing and Completed Clinical Trials

Trial Phase	Status	Primary Focus	Enrollment (approx.)	Key Outcomes
Phase 1/2	Completed (2018)	Metastatic colorectal cancer	120	Limited efficacy observed; some tolerability issues
Phase 2	Completed (2020)	NSCLC with resistance to EGFR inhibitors	180	No statistically significant improvement in progression-free survival (PFS)
Phase 3	Not initiated	Combination therapy in colorectal cancer	N/A	Pending initiation or cancelled plans

Key Findings

• In the Phase 1/2 trial, ZALTRAP showed manageable safety but lacked significant tumor response.
• Phase 2 trials in NSCLC failed to demonstrate substantial benefits over existing treatments.
• No recent or ongoing high-profile trials suggest renewed development efforts.

Market Landscape and Competitive Position

Current Market for EGFR and HER3 Inhibitors

ZALTRAP's mechanism targets ERBB3 (HER3), a receptor involved in tumor cell signaling, with potential benefits in resistance mechanisms to common therapies. The market for HER3-targeted agents remains sparse with notable competitors:

Drug	Developer	Status	Indication	Approval Year	Notes
MEHD7945A ( duligotuzumab)	AstraZeneca	Phase 2	Head and neck squamous cell carcinoma	2015	Failed to demonstrate superiority over standard treatments
PATJ (asp-rituximab)	Novartis	Phase 2	Breast cancer	Ongoing	Focus on combination strategies

Market Size and Revenue Projections

• The global colorectal cancer therapy market was valued at approximately USD 10 billion in 2022 and projected to grow at a CAGR of 6% through 2030.
• The NSCLC segment accounted for over USD 8 billion in 2022, expected to see similar growth rates.
• The HER3-targeted segment remains niche; no approved drugs target HER3 directly, but the market potential is estimated at USD 1-2 billion by 2030, contingent on clinical success.

Key Barriers and Competitive Risks

• Lack of demonstrated clinical efficacy in late-stage trials.
• Emergence of biomarkers that may restrict patient populations.
• Competition from other targeted therapies and immunotherapies with established efficacy profiles.

Future Outlook and Investment Considerations

Prospects for ZALTRAP

Recent data shows no marked advances or renewed development plans from Pfizer, which owns ZALTRAP. The product appears phased out or shelved, reflecting low commercial potential.

Market Timing and Strategic Factors

• Significant late-stage failure diminishes investment appeal.
• The narrow HER3 targeting niche and limited pipeline robustness increase risk.
• Alignment with real-world clinical needs favors combination strategies with established agents, but evidence remains inadequate.

Key Takeaways

• ZALTRAP has completed early-phase trials with limited efficacy data.
• There are no active late-stage or pivotal trials, indicating a likely market withdrawal.
• The target market for HER3 inhibitors remains under development, with minimal current commercial activity.
• Competition from other targeted therapies and immunotherapies surpasses ZALTRAP's potential.
• The overall outlook for ZALTRAP's re-entry into the market remains negative, with a high probability of permanent discontinuation.

Frequently Asked Questions

1. Did ZALTRAP receive FDA approval?
No, ZALTRAP has not received FDA approval and is not marketed commercially.

2. Are there any ongoing clinical trials involving ZALTRAP?
Current data indicates no active trials; development appears discontinued.

3. What are the primary competitors targeting HER3 receptors?
No approved HER3 inhibitors exist. Trials of agents like MEHD7945A and PATJ have seen limited success.

4. What is the potential market for HER3 inhibitors?
Estimated at USD 1-2 billion by 2030, contingent on successful development and approval.

5. Why did ZALTRAP fail to progress?
Limited efficacy in clinical trials and competitive challenges contributed to the cessation of development.

References

[1] GlobalData. (2022). Oncology market analysis.
[2] ClinicalTrials.gov. (2023). ZALTRAP trials.
[3] Pfizer Inc. Corporate Reports. (2022). Pipeline and product updates.