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Microsatellite High CancersPhase 2NCT05337735

A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers

A Phase 2 study testing XmAb20717 in people with Microsatellite High Cancers and Peritoneal Mesothelioma, run by M.D. Anderson Cancer Center at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

To test the safety of and effectiveness of XmAb20717 for participants with advanced rare cancers. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
XmAb20717
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteUnited States
Study dates
5 Aug 2022to 30 Dec 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is able to complete signed informed consent. Patients for whom English is not their primary language are eligible for participation with translator assistance during the informed consent process.
  • Is of age ≥ 18
  • Is able, in the investigator's judgment, to comply with the study protocol
  • Has measurable disease according to RECIST v1.1 The pleural mesothelioma cohort will require measurable disease according to either modified RECIST or RECIST; the Hodgkin lymphoma patients will be assessed by the 2014 Lugano criteria (see Appendix F)
  • Has an ECOG performance status of 0 - 1
  • Has adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
Show all 44Show fewer
  • ANC ≥ 1.0×109/L without granulocyte colony-stimulating factor support (for the lymphoma cohort only, Absolute neutrophil count of ≥ 1.0×109/L without growth factor support for 3 days prior to screening assessment.)
  • Lymphocyte count ≥ 0.5×109/L
  • Platelet count ≥ 100× 109/L without transfusion (for the lymphoma cohort only: platelet count of ≥ 50×109/L without transfusion for 3 days prior to screening assessment)
  • Hemoglobin ≥ 90 g/L (for the lymphoma cohort only: Hemoglobin >80 g/L without transfusion for 3 days prior to screening assessment) (For platelet count and hemoglobin, patients may be transfused to meet either criterion but not within 14 days prior to initiation of study treatment)
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5× upper limit of normal (ULN), with the following exceptions:
  • Patients with documented liver metastases: AST and ALT ≤ 5×ULN
  • Patients with documented liver or bone metastases: ALP ≤ 5×ULN
  • Serum bilirubin ≤ 1.5 ×ULN with the following exception:
  • Serum creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min OR 24-hour urine creatinine clearance ≥50 mL/min
  • Serum albumin ≥ 2.5 g/dL
  • For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5×ULN
  • For patients receiving therapeutic anticoagulation: is on a stable anticoagulant regimen without changes in agent and / or dose in the past 30 days
  • Must agree to use a highly effective method of birth control (as defined in Section 7.4.1) (female patients and male patients with female partners of childbearing potential) during and for 6 months after last dose of study treatment. Also see related information in Section 6.6.10.8.
  • .
  • Basket-specific Inclusion Criteria:
  • Peritoneal Mesothelioma: Has advanced MPeM that was previously treated with and refractory/intolerant to platinum-pemetrexed systemic chemotherapy or has not received treatment and is ineligible for platinum-pemetrexed treatment
  • Pleural Mesothelioma: Has unresectable MPM and is treatment naïve or has received any line of prior therapy, including anti-PD1/anti-PDL1/anti-CTLA4.
  • High-grade Neuroendocrine Carcinoma: Has extra-pulmonary site carcinoma (small-cell- and large-cell lung cancer excluded) and has received therapy with a platinum-based chemotherapy regimen
  • MSI-H Cancers: Has not had anti-PD1 / anti-PDL1 / anti-CLTA4 therapyMSI-H/dMMR, locally advanced or metastatic solid tumors. Locally advanced solid tumors are defined by having ≥20% chance of recurrence with surgery alone. Patients with localized solid tumors are also eligible if they have a high risk for surgical mortality defined as >5% by ACS National Surgery Quality Improvement Program. Patients being treated with neoadjuvant intent may be treated for up to 6 months prior to surgical resection, though in patients with clear clinical benefit as deemed by treating physicians, a non-operative approach-treatment duration ≥ 6 months (and up to 2 years)-may be considered.
  • Note: ASC = American College of Surgeons, MSI-H = microsatellite instability-high, dMMR = deficient mismatch repair.
  • Lymphoma: Has relapsed, refractory classical Hodgkin lymphoma and has received first-line chemotherapy. Prior treatment with anti-PD1 / PDL1 antibody is not exclusionary.
  • Cervical Cancer: Has recurrent, metastatic, or persistent cervical cancer (squamous cell carcinoma, adenosquamous, or adenocarcinoma of the cervix) and has received at least one prior line of systemic therapy and not amenable to curative treatment. Prior treatment with anti-PD1 / PDL1 antibody is not exclusionary.
  • Small-cell lung cancer: Extensive-stage small-cell lung cancer following treatment with prior platinum-based therapy, which can include prior anti-PD1, anti-PDL1, but not anti-CTLA4.
  • Study Participant Exclusion Criteria:
  • Participants who meet any of the following criteria will be excluded from the study:
  • Received treatment for the studied cancer within 21 days prior to initiation of study treatment
  • Received treatment with targeted therapies or investigational therapies within 21 days or for the duration of 5 half-lives prior to initiation of study treatment
  • Has a history of severe allergic, anaphylactic, or other hypersensitivity reactions to study drug
  • Has active known- or suspected autoimmune disease (allowed are patients with vitiligo; type 1 diabetes mellitus, or residual hypothyroidism due to an autoimmune condition that is treatable with hormone-replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs).
  • Has any condition that requires systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted).
  • Has a history or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary-, renal-, metabolic-, hematologic-, or psychiatric-) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to patient safety or interfere with study evaluations, procedures, or completion.
  • Has had any serious bacterial, viral, parasitic, or systemic fungal infections within 14 days prior to the first dose of study drug.
  • Received prior treatment with any checkpoint-inhibitor therapy regimen that targets PD1/PDL1 or CTLA-4 (this does not apply to candidates for the lymphoma, pleural mesothelioma, cervical cancer or SCLC cohorts-see basket-specific inclusion criteria).
  • Received a live-virus vaccine within 30 days prior to first dose of study drug (vaccines that do not contain live virus are permitted).
  • Has another malignancy, except for non-melanoma skin cancer, in situ cervical cancer, or bladder cancer (Tis and T1) that has been adequately treated during the 3 years prior to screening (Note: For MSI-H cohort, prior history of malignancies are allowed unless this may be a competing risk for mortality while on study per the investigator).
  • Has untreated or unstable brain metastases. Allowed are those with known brain metastases who have been previously treated and are asymptomatic. If prior local therapy was received, it must have been completed at least 14 days prior to receiving study drug.
  • Has evidence of current ILD or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids
  • Is breastfeeding or plans to initiate breastfeeding during the study treatment or within 6 months of taking study treatment.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

To test the safety of and effectiveness of XmAb20717 for participants with advanced rare cancers.

Read the detailed description

Primary Objective:

Efficacy of XmAb20717 as defined by objective response (defined as a complete response [CR] or partial response [PR] on two consecutive occasions ≥4 weeks apart) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)

Secondary Objectives:

  1. Objective response as determined by an independent radiologist according to immune-modified RECIST
  2. Progression-free survival (PFS) (defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma).
  3. Duration of response (DoR) (defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)
  4. Disease control as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)
  5. Overall survival (OS) (defined as the time from enrollment to death from any cause)
  6. PFS as determined by an independent radiologist according to immune-modified RECIST
  7. DoR as determined by an independent radiologist according to immune-modified RECIST
  8. Disease control as determined by an independent radiologist according to immune-modified RECIST
  9. Occurrence and severity of AEs, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0

Exploratory Objective

To identify biomarkers that are predictive of response and/or are associated with progression to a more severe disease state (i.e., prognostic biomarkers).

Being tested
XmAb20717
Medical subject headings
Carcinoma, Neuroendocrine, Uterine Cervical Neoplasms, Hodgkin Disease, Mesothelioma, Malignant, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XmAb20717Drug

    Given by vein (IV)

Study groups in NCT05337735
Study groupRoleWhat they receive
XmAb20717ExperimentalParticipants will receive XmAb20717 by vein over 1 hour on Days 1 and 15 of each cycle.
Receives: Drug: XmAb20717

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To establish the efficacy of XmAb20717 as measured by overall response rate.

    Number of Participants With Objective Radiographic response as Assessed by RECIST v.1.1

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start5 Aug 2022
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Why it stopped: PI Request

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337735
Sponsor's protocol ID
2021-0589
Other IDs
NCI-2022-02841
Status last verified
Oct 2026
First submitted
28 Mar 2022
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XmAb20717 in people with Microsatellite High Cancers and Peritoneal Mesothelioma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To establish the efficacy of XmAb20717 as measured by overall response rate. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05337735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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