A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL - 2 Superkine, Administered Alone or in Combination with Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors

Cancer Categories

Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin

Karmanos Trial ID

2023-053

NCT ID

NCT05086692

Age Group

Adult

Scope

National

Phase

Phase I/II

Principal Investigator

Ira
Winer, MD, PhD, FACOG
Oncology - Gynecologic, Oncology - Surgical View Profile

Objective:

Dose Escalation (Monotherapy)

Primary Objectives:

To evaluate safety and tolerability of MDNA11 administered in patients with advanced solid tumors
To identify RDE and/or MTD of MDNA11.

Secondary Objectives:

To assess anti-tumor activity of MDNA11
To assess pharmacokinetic (PK) profile of MDNA11
To assess immunogenicity of MDNA11
To assess pharmacodynamic effects of MDNA11

Dose Expansion (Monotherapy and Combination Therapy)

Primary Objectives:

To further evaluate safety and tolerability of MDNA11 (alone or in combination with pembrolizumab)
To assess anti-tumor activity of MDNA11 (alone or in combination with pembrolizumab)

Secondary Objectives:

To assess pharmacodynamic effects of MDNA11 (alone or in combination pembrolizumab) in peripheral blood
To assess pharmacodynamic effects and immune response of MDNA11 (alone or in combination pembrolizumab) in tumor tissue
To further assess PK profile of MDNA11
To assess immunogenicity of MDNA11 (alone or in combination pembrolizumab)

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Eligibility

Inclusion Criteria:

Aged at least 18 years (inclusive at the time of informed consent).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
Demonstrated adequate organ function
Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.
Life expectancy of ≥ 12 weeks.
Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.
Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.

Exclusion Criteria:

Last administration of prior antitumor therapy:

Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.
Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (<2 weeks of radiotherapy) to non-CNS disease.
Radiation therapy to the lung that is > 30Gy within 6 months prior to start of treatment.
Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.

Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.
Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.
Condition requiring long-term systemic treatment with either corticosteroids > 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.
Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.
Severe pulmonary, cardiac or other systemic disease.
Known hepatitis B or C virus infection.
Females who are pregnant or lactating or planning to become pregnant during the study.
Has had an allogeneic tissue/solid organ transplant.
Active infection requiring systemic therapy.
Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol
Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.
Known severe hypersensitivity to any component of study drug(s).
Inability to comply with study and follow up procedures as judged by the Investigator.

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
Get Directions

Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices