PDS01ADC for Advanced Kaposi Sarcoma
This study is looking into two non-chemotherapy drugs, PDS01ADC and M7824, for people with advanced Kaposi sarcoma (KS). KS is a type of tumor that can grow in different parts of the body. PDS01ADC works by triggering your immune system to fight tumors. M7824 blocks pathways that cancer cells use to hide from your immune system. Researchers want to see if PDS01ADC alone or combined with M7824 can help your immune system fight KS tumors. You may be able to join if you are 18 to 99 years old, have KS confirmed by a biopsy, and your KS requires systemic treatment. The main goals are to check the safety, how well people tolerate the treatments, and how effective they are. These will be measured for up to 24 treatment cycles, or until the disease worsens, side effects are too severe, or you leave the study.
- Study design
- This interventional study plans to enroll 80 participants. It is not specified if it is randomized or blinded.
- What's involved
- PDS01ADC is given as a shot under the skin every 4 weeks. M7824 is given through a vein every two weeks while you are also receiving PDS01ADC.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed until the disease progresses, side effects are too severe, or they withdraw from the study, for up to 24 treatment cycles.
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NCT04303117
PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma
Recruiting
PHASE1Ages 18–99InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~80 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:PDS01ADCM7824
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
safety, tolerability and activity of PDS01ADC alone or in combination with M7824
Measured over 24 cycles of treatment, until confirmed progression, unacceptable toxicity or trial withdrawal
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Ramya M Ramaswami, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Individuals with biopsy proven (confirmed in the Laboratory of Pathology \[LP\], CCR) Kaposi sarcoma (KS)
KS requiring systemic therapy, with or without history of prior KS therapy:
T1 KS or T0 KS sufficiently widespread that systemic therapy is advisable, or KS affecting quality-of-life due to local symptoms or psychological distress
KS with an inadequate response to liposomal doxorubicin, paclitaxel, other systemic chemotherapy (either progressive disease or stable disease after 3 or more cycles) or immunotherapy (progressive disease)
A wash-out period off treatment of 2 weeks from last chemotherapy and 4 weeks from last immunotherapy, other systemic treatment with a biologic agent, or monoclonal antibody therapy will be required in individuals with prior KS therapy.
Resolution of toxicity from prior therapy to \<= Grade 1.
At least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.
Measurable disease by the criteria proposed by the AIDS Clinical Trials Group (ACTG) Oncology Committee for KS
HIV positive or negative.
ART for HIV+ individuals for 8 or more weeks prior to entry with an HIV viral load of \<400 copies/ml at screening and CD4+ T cell count of \>= 50 cells/microliter as this may be expected if individuals have received several courses of chemotherapy.
Age \>=18 years.
ECOG performance status \<=2 (Karnofsky \>=60%).
Adequate organ and marrow function as defined below:
Absolute neutrophil count \>=1,000/mcL
Platelets \>=100,000/mcL
Total bilirubin within normal institutional limits; OR \<3x institutional upper limit of normal (ULN) for Gilbert s syndrome or HIV protease inhibitors; OR \<5x ULN and direct bilirubin \< 0.7mg/dL for individuals on atazanavir-containing HIV regimen
AST/ALT \<=1.5 X institutional ULN
Hemoglobin \>= 9g/dL
Creatinine within normal institutional limits OR creatinine clearance \>30 mL/min/1.73m\^2 as estimated by either Cockroft-Gault of 24- hour urine collection if creatinine levels above institutional normal
Normal international normalized ratio (INR), prothrombin time (PT) \<= 1.5 x ULN, and activated partial thromboplastin time (aPTT) \<= 1.5 x ULN (required only if participants will receive M7824)
The effects of PDS01ADC and M7824 on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and individuals able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during treatment and for at least 4 months after the last dose of treatment and agree to inform the treating physician immediately if they become pregnant. Also, there is unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M7824 and/or PDS01ADC, therefore WOCBP must agree to discontinue nursing if treated with these agents.
Ability of individual to understand and the willingness to sign a written informed consent document.
Exclusion
Receiving any other investigational agents.
Pregnant individuals are excluded from this study as the effects of PDS01ADC and M7824 have potential teratogenic or abortifacient effects.
Severe KS (such as symptomatic pulmonary KS) that could be life threatening if it progressed over 2-4 weeks
Actively bleeding sites caused by visceral KS.
Unwilling to accept blood products as medically indicated
Actively bleeding and/or requiring transfusions in the 2 weeks preceding study entry.
History of bleeding, diathesis, or recent major bleeding events within a period of 4 weeks considered by the investigator as high risk for investigational drug treatment.
Any active or recent history (symptomatic in the last 3 months) of a known or suspected autoimmune disease (with the exception of diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment) or recent history of a syndrome that required systemic corticosteroids (10mg daily prednisone or equivalent) or immunosuppressive medications except inhaled steroids and adrenal replacement steroids doses up to 10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
Uncontrolled opportunistic infections
Active multicentric Castleman disease
Individuals with primary effusion lymphoma
History of malignant tumors other than KS, unless:
In complete remission for \>= 3 years from the time complete remission was first documented or
Resected basal cell or squamous cell carcinoma of the skin or
In situ cervical or anal dysplasia
History of allergic reactions attributed to compounds of similar chemical or biologic composition to PDS01ADC and/or M7824 investigational agents used in study.
Active tuberculosis (TB):
Individuals who are undergoing first month of therapy (RIPE or equivalent) for active TB or
Individuals with TB immune reconstitution syndrome (IRIS) requiring corticosteroids
Received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.
Uncontrolled substantial intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, that would limit compliance with study requirements.
Medical or psychiatric illness or social situation that would, in the opinion of the investigator, preclude participation in the study or the ability of individuals to provide informed consent for themselves.
Uncontrolled HBV infection, defined as plasma HBV DNA detectable by PCR
A positive hepatitis B serology indicative of previous immunization (i.e. HbsAb positive and HbcAb negative), or a fully resolved acute HBV infection
Chronic HBV suppressed by appropriate antiretroviral therapy with activity against HBV, as outlined in DHHS guidelines.
Uncontrolled HCV infection, defined as plasma HCV DNA detectable by PCR
Positive HCV serology but no detectable HCV RNA, indicative of spontaneously cleared HCV infection
Successfully treated for HCV as long as therapy for HCV has been completed.
Individuals will be excluded from the combination therapy arm if:
they have discontinued prior PD1/L1 blocking agent due to immune mediated adverse event(s) OR
they have active non-infectious pneumonitis or a history of steroid requiring non-infectious pneumonitis.
What this trial measures
- safety, tolerability and activity of PDS01ADC alone or in combination with M782424 cycles of treatment, until confirmed progression, unacceptable toxicity or trial withdrawal
The fraction of participants with toxicity noted at each dose level will be reported by grade and type of toxicity identified. Maximum tolerated dose will also be reported.