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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    140
  • sponsor
    M.D. Anderson Cancer Center
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Updated on 18 October 2022
See if I qualify
platelet count
cancer
total bilirubin
lymphoma
granulocyte colony stimulating factor
systemic therapy
measurable disease
carcinoma
lung cancer
treatment regimen
serum bilirubin
colony stimulating factor
pemetrexed
chemotherapy regimen
aptt
cancer chemotherapy
adenocarcinoma
neuroendocrine carcinoma
atezolizumab
refractory classical hodgkin lymphoma
classical hodgkin lymphoma
xmab20717

Summary

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

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).

Details
Condition Microsatellite High Cancers, Peritoneal Mesothelioma, Extrapulmonary High Grade, Neuroendocrine Carcinomas, Cervical Carcinoma, Hodgkin's Lymphoma, Pleural Mesothelioma, Small Cell Lung Cancer
Treatment XmAb20717
Clinical Study IdentifierNCT05337735
SponsorM.D. Anderson Cancer Center
Last Modified on18 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Inclusion Criteria
Is able to complete signed informed consent
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
ANC ≥ 1.0×109/L without granulocyte colony-stimulating factor support
Lymphocyte count ≥ 0.5×109/L
Platelet count ≥ 100× 109/L without transfusion
Hemoglobin ≥ 90 g/L (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
o Serum bilirubin ≤ 1.5 ×ULN with the following exception: Patients with known Gilbert
disease: serum bilirubin level ≤ 3 ×ULN
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
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](telnet://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
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 therapy, non-colorectal-
or colorectal- (the latter limited to ≤ 25% of total accrual) MSI-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
Cervical Cancer: Has recurrent, metastatic, or persistent cervical cancer (squamous
cell carcinoma, adenosquamous, or adenocarcinoma of the cervix) which has not been
treated with systemic therapy (except as part of chemoradiation) and not amenable to
curative treatment
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

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
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 pleural mesothelioma 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
Is breastfeeding or plans to initiate breastfeeding during the study treatment or
within 6 months of taking study treatment
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platelet count
cancer
total bilirubin
lymphoma
granulocyte colony stimulating factor
systemic therapy
measurable disease
carcinoma
lung cancer
treatment regimen
serum bilirubin
colony stimulating factor
pemetrexed
chemotherapy regimen
aptt
cancer chemotherapy
adenocarcinoma
neuroendocrine carcinoma
atezolizumab
refractory classical hodgkin lymphoma
classical hodgkin lymphoma
xmab20717

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