A Trial of AVID200, a Transforming Growth Factor β (TGFβ) Inhibitor, in Patients Malignancies

Inclusion Criteria:

* Patients with a documented (histologically or cytologically proven) solid tumor malignancy that is locally advanced or metastatic
* Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
* Patients with a malignancy that is either refractory to, or the patient is intolerant of existing therapy(ies) known to provide clinical benefit, or for which no standard therapy is available
* Patients with measurable or non-measurable disease according to RECIST, v1.1
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (or equivalent Karnofsky PS), and anticipated life expectancy of ≥ 3 months
* Patients and their partners who are either not of childbearing potential or who agree to use a highly effective, non-hormonal, method of contraception during the study and continuing until 4 months after the last dose of study drug); male patients agreeing to refrain from sperm donation during this period.
* Patients with the ability to understand and give written informed consent for participation

Exclusion Criteria:

* Patients with an active second malignancy or history of another malignancy within the last 2 years with the exception of:

  * Treated non-melanoma skin cancers
  * Treated carcinoma in situ (CIS) of the breast, cervix, bladder, colon, endometrium, skin (melanoma) provided complete response (CR) was achieved at least 2 years prior to study and no additional therapy is ongoing or required during study period with the exception of anti-estrogen/androgen therapy or bisphosphonates
  * Controlled, superficial carcinoma of the bladder
  * T1a carcinoma of the prostate comprising \< 5% of resected tissue and prostate specific antigen (PSA) within normal limits (WNL) since resection
* Any antineoplastic agent for the primary malignancy (standard or investigational), without delayed toxicity, within 4 weeks or 5 plasma half-lives, whichever is shortest, prior to C1/D1 and during study with the exception of:

  -Nitrosoureas and mitomycin C within 6 weeks prior to C1/D1 and during study
* Any other investigational treatments within 4 weeks prior to and during study; includes participation in any medical device or supportive care therapeutic intervention trials
* Radiotherapy for target lesions within 4 weeks prior to C1/D1 and during study; radiotherapy for non-target lesions within 2 weeks prior to C1/D1
* Radiotherapy within 2 weeks prior to C1/D1 and during study. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
* Use of live vaccines against infectious diseases 4 weeks prior to C1/D1 and during study
* Immunosuppressive or systemic hormonal therapy (\> 10 mg daily prednisone or equivalent) within 2 weeks prior to C1/D1 and during study
* Prophylactic use of hematopoietic growth factors within 2 weeks prior to C1/D1 and during Cycle 1 of study; thereafter prophylactic use of growth factors is allowed as clinically indicated