A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors

Plain English Summary

A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors is a Phase 1 clinical trial sponsored by Seagen, a wholly owned subsidiary of Pfizer studying Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma. This study tests the safety and side effects of a new drug, PF-08046049/SGN-BB228, in adults with advanced melanoma or other solid tumors that have not responded to standard treatments. It is for patients with specific types of advanced cancers, including melanoma, non-small cell lung cancer, colorectal cancer, pancreatic cancer, and mesothelioma. Participation involves receiving the study drug intravenously. The study has multiple parts to determine the right dose and evaluate safety and potential effectiveness. Alternative treatments may include other standard therapies or investigational drugs depending on the patient's specific cancer and prior treatments. The trial aims to enroll 41 participants.

Official Summary

This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. This study will have 3 parts. Parts A and B of the study will find out how much PF-08046049/SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid tumor cancers.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with advanced melanoma or other solid tumors (lung, colorectal, pancreatic, mesothelioma) that have relapsed, are resistant to treatment, or are not tolerated by standard care. Must have had prior treatment for melanoma, including immunotherapy (anti-PD-1/PD-L1), and if applicable, BRAF/MEK targeted therapy. Patients must have a good general health status (ECOG score of 0 or 1) and measurable disease. Cannot have active brain metastases or certain other active cancers, or have received prior treatments targeting CD228 or 4-1BB. This trial is studying Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure the frequency and severity of any unexpected health problems or abnormal lab results caused by the drug, helping to understand its safety profile. The specific primary outcome measures are: Number of participants with adverse events (AEs) (Through 30 days after the last study treatment; approximately 7 months); Number of participants with laboratory abnormalities (Through 30 days after the last study treatment; approximately 7 months); Number of participants with dose limiting toxicities (Up to 28 days). 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 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial addresses a critical need for new treatments for advanced solid tumors, particularly melanoma, that have become resistant to existing therapies. This research targets Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma, where improved treatment options are needed.

Investor Insight

This Phase 1 study, sponsored by Seagen (a Pfizer subsidiary), is an early-stage investigation into a novel drug, indicating a significant investment in exploring new oncology treatments in a competit Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the study drug, potential side effects, and how it might interact with your current health conditions or medications. Participation involves regular clinic visits for drug administration, monitoring of side effects, and tests to assess disease status. Be prepared for potential side effects and discuss any new or worsening symptoms with your healthcare team immediately. 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

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 41 participants

Interventions

• DRUG: PF-08046049 — Given into the vein (IV; intravenous)

Primary Outcomes

• Number of participants with adverse events (AEs) (Through 30 days after the last study treatment; approximately 7 months)
• Number of participants with laboratory abnormalities (Through 30 days after the last study treatment; approximately 7 months)
• Number of participants with dose limiting toxicities (Up to 28 days)

Secondary Outcomes

• Number of participants with antidrug antibodies (Through 30 days after the last study treatment; approximately 7 months)
• Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Through 30 days after the last study treatment; approximately 7 months)
• PK parameter - Maximum Concentration (Cmax) (Through 30 days after the last study treatment; approximately 7 months)
• PK parameter - Time to maximum concentration (Tmax) (Through 30 days after the last study treatment; approximately 7 months)
• PK parameter - Apparent terminal half-life (t1/2) (Through 30 days after the last study treatment; approximately 7 months)

Full Eligibility Criteria

Inclusion Criteria:

* All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.
* Participants must have one of the following tumor types:

  * Parts A and B: Participants must have metastatic or unresectable cutaneous melanoma.
  * Part C: Participants must have one of the following tumor types:

    * Cutaneous Melanoma
    * Non-small Cell Lung Cancer (NSCLC)
    * Colorectal Cancer (CRC)
    * Pancreatic Cancer
    * Mesothelioma
* A pre-treatment biopsy or submission of archival tissue is required
* For participants with cutaneous melanoma

  * Must have been previously treated with an anti-programmed death-1 (anti-PD-1) or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other therapies.
  * Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or been deemed ineligible to receive treatment with BRAF/MEK targeted therapy prior to study entry.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Measurable disease per RECIST v1.1 at baseline

Exclusion Criteria:

* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
* Active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are:

  * clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
  * they have no new or enlarging brain metastases,
  * and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
* Prior therapies cannot include any drugs targeting CD228 or 4-1BB
* Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment
* Melanoma subtypes including acral, uveal, and mucosal are excluded

Trial Locations

• UCLA Hematology/Oncology - Administrative Office, Los Angeles, California, United States
• The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate, Los Angeles, California, United States
• Cedars-Sinai Medical Center, Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center, Drug Information Center, Los Angeles, California, United States
• UCLA Hematology/Oncology, Los Angeles, California, United States
• UCLA Hematology/ Oncology- Pasadena, Pasadena, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
• UCSF Medical Center, Investigational Pharmacy, San Francisco, California, United States
• UCLA Hematology/Oncology - Santa Barbara, Santa Barbara, California, United States
• The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only), Santa Monica, California, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Melanoma
• Non-small Cell Lung Cancer
• Colorectal Cancer
• Pancreatic Cancer
• Mesothelioma
• Solid Tumors
• Oncology
• Immunotherapy
• Cancer Treatment
• Advanced Cancer

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