Last updated on October 2020

A Study of XmAb 22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Early | Islet Ce417ll Cancer | Endometrial Cancer | Nasopharyngeal Cancer | Injection Port | Primary Immunodeficiency | Mismatch Repair Deficiency | Epithelial Ovarian Cancer | Malignant neoplasm of kidney | Vaginal Atrophy | Skin Wounds | Non-Small Cell Lung Cancer | Recurrent | Fallopian Tube Cancer | Kidney Cancer | Adenocarcinoma | melanoma | Liver Cancer | Intrahepatic Cholangiocarcinoma | Near-Sighted Corrective Surgery | Primary Peritoneal Carcinoma | Pancreatic Cancer | skin cancer | MSI-H | Anal Dysplasia | Vulvar Dysplasia and Carcinoma | Small Cell Lung Cancer | Brain Function | Malignant neoplasm of prostate | Breast Cancer - HER2 Positive | Colorectal Cancer | Cervical Intraepithelial Neoplasia | Diet and Nutrition | Chronic Diarrhea | Chronic Shoulder Pain | Endometrial Carcinoma | Renal Cancer | Recurrent Respiratory Papillomatosis | Transitional cell carcinoma | Cervical Cancer | Peripheral Arterial Occlusive Disease | Metastatic Triple-Negative Breast Cancer | Razor Bumps (Pseudofolliculitis Barbae) | Colon cancer; rectal cancer | Pediatric Health | Adverse Effects | Drugs | Advanced Malignancies | Squamous Cell Carcinoma of the Head and Neck | Triple Negative Breast Cancer | Carcinoma | HEPATIC NEOPLASM | Malignant Melanoma | Renal Cell Cancer | Renal Cell Carcinoma | Colon Cancer Screening | Breast Cancer | Malignant Adenoma | Gastric or Gastroesophageal Junction Adenocarcinoma | Prostate Cancer | HEPATOCELLULAR CARCINOMA | Advanced or Metastatic Solid Tumors | Urothelial Carcinoma | Metastatic Melanoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. All subjects' cancer must have progressed after treatment with all available therapies that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment.
  2. All subjects must have adequate archival tumor, or give consent to a fresh tumor biopsy.
  3. Subjects have an ECOG performance status of 0-1.
  4. Subjects in monotherapy and combination therapy cohorts must have histologically or cytologically confirmed advanced or metastatic solid tumors, including the following:
  5. Melanoma (excluding uveal melanoma)
  6. Cervical carcinoma
  7. Pancreatic carcinoma
  8. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (TNBC)
  9. Hepatocellular carcinoma
  10. Urothelial carcinoma
  11. Squamous cell carcinoma of the head and neck (HNSCC)
  12. Nasopharyngeal carcinoma (NPC)
  13. Renal cell carcinoma
  14. Microsatellite instability-high or mismatch repair deficient tumors
  15. Small cell lung carcinoma or NSCLC
  16. Gastric or gastroesophageal junction adenocarcinoma
  17. Prostate adenocarcinoma
  18. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
  19. Intrahepatic cholangiocarcinoma
  20. Subjects in the combination cohorts in Part A with XmAb22841 and pembrolizumab may have an advanced solid tumor that either:
    • has progressed after treatment with all available therapies that are known to confer clinical benefit, or is intolerant or has refused standard treatment (as for the XmAb22841 monotherapy cohorts), or
    • is of a tumor type for which pembrolizumab is an approved indication and has not previously been treated with an agent targeting PD1 or PDL1.

Exclusion Criteria:

  1. Prior treatment with an investigational anti-LAG3 therapy.
  2. Treatment with any CTLA4 antibody within 16 weeks of the start of study drug for Cohorts 1M, 2M, 3M, 1P, and 2P; within 8 weeks for Cohorts 4M, 5M, 3P, and 4P; and within 3 weeks for Cohorts 6M, 7M, 5P, and 6P.
  3. Systemic antineoplastic therapy, unconjugated antibody therapy within 4 weeks of the first dose of study treatment; or radiotherapy within 2 weeks of the first dose of study treatment; or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
  4. Have received prior therapy with an anti-PD1, anti-PDL1, or anti PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA4, OX 40, CD137) AND were permanently discontinued from that treatment due to an IRAE.
  5. Failure to recover from any IRAE from prior cancer therapy to Grade 1.
  6. Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade 2.
  7. Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; 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).
  8. Receipt of an organ allograft.
  9. Treatment with antibiotics within 14 days prior to first dose of study drug.
  10. Participants with known HIV.
  11. Participants with known chronic hepatitis B virus (HBV) infection treated for less than 3 months prior to study enrollment and/or with a detectable HBV viral load; or hepatitis C virus (HCV) infection that has been treated for less than 4 weeks prior to study enrollment and/or with a detectable HCV viral load; or active HBV/HCV coinfection.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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